Means and method of replacing a heart valve in a minimally invasive manner

ABSTRACT

A heart valve can be replaced using minimally invasive methods which include a sutureless sewing cuff that and a fastener delivery tool that holds the cuff against the patient&#39;s tissue while delivering fasteners to attach the cuff to the tissue from the inside out. The tool stores a plurality of fasteners and is self-contained whereby a fastener is delivered and placed all from inside a vessel. The fasteners are self-forming whereby they do not need an anvil to be formed. Anchor elements are operated from outside the patient&#39;s body to cinch a prosthesis to an anchoring cuff of the valve body. The cuff is releasably mounted on the tool and the tool holds the cuff against tissue and drives the fastener through the cuff and the tissue before folding over the legs of the fastener whereby secure securement between the cuff and the tissue is assured. Fasteners are placed and formed whereby fasteners are located continuously throughout the entire circumference of the cuff. A minimally invasive surgical method is disclosed, and a method and tool are disclosed for repairing abdominal aortic aneurysms in a minimally invasive manner. Fasteners that are permanently deformed during the process of attaching the cuff are disclosed as are fasteners that are not permanently deformed during the attaching process.

CROSS REFERENCE TO RELATED APPLICATIONS

The application is a continuation-in-part (CIP) of U.S. Ser. No.08/964,026 filed on Nov. 4, 1997 and now abandoned, which is a CIP ofU.S. Ser. No. 08/802,948 filed on Feb. 21, 1997 and now U.S. Pat. No.6,042,607, which is a CIP of U.S. Ser. No. 08/606,343 filed on Feb. 23,1996, now U.S. Pat. No. 5,716,370.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to the general art of prosthetic devices,and to the particular field of prosthetic heart valves and surgicaltools, fasteners and techniques associated therewith.

BACKGROUND OF THE INVENTION

It is well known that heart diseases may result in disorders of thecardiac valves. For example, diseases such as rheumatic fever can causethe shrinking or pulling apart of the valve orifice, while otherdiseases may result in endocarditis, an inflammation of the endocardiumor lining membrane of the heart. The resulting defects in the valveshinder the normal functioning of the atrioventricular orifices andoperation of the heart. More specifically, defects such as the narrowingof the valve stenosis and/or the defective closing of the valve,referred to as valvular insufficiency, result in an accumulation ofblood in a heart cavity or regurgitation of blood past the valve. Ifuncorrected, prolonged valvular stenosis or insufficiency may causedamage to the heart muscle, which may eventually necessitate total valvereplacement.

These defects may be associated with any of the cardiac valves. Forexample, if the mitral valve stenosis connecting the left auricle withthe left ventricle narrows, blood will accumulate in the left auricle.Similarly, in the case of mitral insufficiency, the mitral valve doesnot close perfectly, and blood in the left ventricle is regurgitatedpast the closed mitral valve into the left auricle when the ventriclecloses.

In many cases, complete valve replacement is required. Mechanicalartificial heart valves for humans are frequently fabricated fromtitanium, prolitic carbon or tissue, including tissue from cows, pigs orhumans. Such valves have been used because of their nonthrombogenicproperties. Human blood does not coagulate on contact with such valves.Moreover, they are lightweight, hard and quite strong. Therefore, suchvalves have become widely accepted and used by many surgeons. Any newprosthetic valve or surgical technique associated therewith shouldaccount for this. One popular prosthetic valve includes such a hard bodyand a knit fabric sewing or structure cuff fixedly attached thereto asby drawstrings made of plastics-type material. The sewing cuff issutured in place on the patient's tissue, and that tissue grows into thefabric providing a secure seal for the prosthetic valve. As will bediscussed below, even though this is a widely accepted valve, there areproblems and drawbacks.

A standard implantable mechanical heart valve usually has an annularvalve housing or body to provide a passageway for blood. Occulders aremounted in the annular body and open or close the blood flow passageway.Usually there are one or two occulders, but occasionally triple occluderconfigurations have been proposed. On the outside of the valve bodythere is usually an external, circumferential surface configured as agroove. The purpose of this groove is to facilitate attachment of theabove-discussed suture ring to the valve body.

As above mentioned, replacement of heart valves has become a widelyaccepted procedure. Currently, as many as eighty thousand heart valveprostheses are implanted in the United States alone. This procedure isvery expensive. It requires the talents of a highly skilled surgeon,perfusionist and anesthesiologist as well as the supporting staff andequipment required to keep the patient on a heart/lung bypass machineduring the operation. While this procedure currently works very well,operating time is still extensive and the longer the patient is onbypass equipment, the greater the risk to the patient. Furthermore, handsuturing is tedious and time consuming further lengthening the time thepatient is on cardiopulmonary bypass and hypothermia. This may increasethe chances of tissue damage to the patient.

Therefore, there is a need for a heart valve replacement procedure thatreduces the surgical time required for the operation.

Still further, many currently used surgical techniques are invasive andoften require breaking of bones. This increases the time and difficultyof the recovery. Therefore, there is a need to develop a prostheticheart valve and a procedure for implanting same that reduces theinvasiveness of this surgery.

As above mentioned, hand suturing of prosthetic heart valves in place iswidely accepted. However, this requires the opening of the patient'schest wall to gain access to the aortic valve through a transverseincision in the ascending aorta. The distance from the incision down tothe valve is usually two to two and one halve centimeters with an aorticlumen diameter of between seventeen and thirty millimeters. This createsa very long and narrow tube into which the surgeon must place sutures.While this is a tedious procedure in an “open chest” case, it is verychallenging to accomplish through any small incision between the ribs orthrough a thoracic inlet, as would be required in any minimally invasiveprocedure. Therefore there is a need for a device and method that cansecure the valve remotely from outside the chest wall.

A further problem associated with suturing some prostheses is that thevalve is bulky and reduces the inside diameter of the valve body. Areduced inside diameter of the valve reduces the flow area of the valveresulting in increased transvalvular pressure gradients resulting inincreased work for the heart muscle. A reduced flow area for such avalve may adversely influence blood flow characteristics associated withthe valve, thereby adversely influencing the performance of the valve.This is very counter-productive to the clinical needs of the prosthesis.It is very hard to develop a mechanical valve that has the same flowcharacteristics of a living tissue valve. This is especially so of manyexisting multi-part prostheses. Even the so-called sutureless valvesthat have been disclosed in the art may have this problem. Heart valvedesigns have been directed toward minimizing the back pressure orrestriction of forward flow by maximizing the cross-sectional area ofthe valve within a given outer diameter base. Housing attachment meanswithin the valve base narrows the inside diameter of the valve bodythereby creating adverse flow characteristics. Therefore, there is aneed for a prosthetic valve which has the flow area thereof maximized.Reduced flow area may also result in rapid blood acceleration with aconcomitant risk of red cell hemolysis and activation of sensitiveenzyme systems such as the clotting system.

Yet a further problem with some prosthetic heart valves and theimplanting procedures associated therewith, is that there are unwantedprojections remaining on the implanted valve. This is especially so forvalves that are sutured in place. Blood clots tend to form aroundforeign objects in the body. The body's natural defenses try to seal offany foreign material and make it non-threatening. However, there is adanger that the formed blood clots may dislodge into the patient's bloodstream, which may cause a major problem.

The sutures used in many existing techniques to sew a cuff in place areknotted and cut off. This leaves raw edges exposed to the patient'sblood stream. These raw edges of the cut off suture and knot providesurfaces for clot formation and provide potential for clots to break offinto the bloodstream as they are newly formed. Loose clots in thebloodstream are dangerous for the patient as they have the potential forproducing a stroke. Clots forming on sutures may also extend onto thevalve and produce malfunctions by trapping the valve open or shut. It iscommon practice to treat a post-surgical patient with heparin or someother anticoagulant to minimize the production of clots. Therefore,there is a need for a prosthetic valve and surgical implanting processthat minimizes the amount of foreign objects that remain exposed to thepatient after the valve has been implanted. The exposed surfaces mayalso become a site of infection. Circulating bacteria may becomeattached and lead to infection at the valve. These infections arenotoriously difficult to treat with antibiotics.

Yet another problem arises because it is difficult to effect a securefit between the prosthesis and the patient's tissue. If there are gapsbetween the lumen and the valve, a leak may develop causing blood tobypass the valve. This can cause disastrous problems. Additionally, inmany of the prostheses that are disclosed in the prior art as beingsutureless, there is no way to ensure close approximation of the aorticlumen to the valve base prior to setting fasteners. This has allowed thelumen to pull away from the base and create the just-mentionedleak-generated problems. This is because anatomy is different frompatient to patient. It is impossible to make the entire spectrum ofvalve bases to accommodate such differences in anatomy as would berequired by some of the systems presently in use. Additionally,differences in diameter are not just in diameter of the lumen, but inthe irregularities of the annulus where the valve is to be placed. Stillfurther, disease and calcification can make the placement of knownvalves unmanageable. Whatever the cause of the imperfect fit between theprosthetic valve and the lumen, the variation in opening size and/orshape must be accounted for in placing the prosthesis. A securelyanchored and tightly fit prosthesis is necessary for a successfuloutcome.

Furthermore, an improper fit between the prosthetic device and the lumenmay greatly increase the duration of the operation or require correctivesurgery to replace an improperly placed prosthesis.

Therefore, there is a need for a prosthesis valve that can be securelyfit to a patient's lumen in an expeditious and reliable manner.

While the art contains several teachings which could be applied to oneor more of the above-mentioned problems, such as the above-discussedcuffs, these disclosures have several drawbacks which are in addition tothose already mentioned. For example, these prosthetic valves generallyinclude a sewing ring or suture cuff that has some sort of stiffenertherein. An example of such a stiffener is soft plastic. Plastic, eveneasily molded plastic, may require the patient's tissue to be severelyhandled and still have puckering even after great precautions have beentaken. In this situation, stiffening elements may be more difficult tohandle than fully flexible elements and may adversely affect thepatient's tissue. Therefore, any new prosthesis valve should use a fullyflexible material to attach that prosthesis to the patient to avoid theproblems of unduly stressing the patient's tissue during the placementof the valve.

Dacron, Polyester and Teflon have been a very popular material forsewing cuffs. It is slightly stretchable, allowing it to be dilated.Needless readily pass through it without tearing or snagging the fabricfibers and the Dacron material has exceptional implant qualities with aproven track record of bioacceptance that allows ingrowth of endothelialcells. Due to its wide acceptance, it will be commercially advantageousto incorporate Dacron into any new prosthesis valve.

Therefore, there is a need for a prosthesis heart valve which can betightly placed in a patient without requiring undue stressing of thepatient's tissue.

There is yet additional need for a prosthesis heart valve which can haveits size and shape expeditiously adjusted to produce a secure,non-leaking, fit to the particular patient, again without placing unduestress on the patient's tissue.

Still further, it is highly desirable for the surgeon to be able toadjust the orientation of the valve in situ. This will permit theprosthesis to be customized to the particular patient. While many knownvalves can be moved in place, there is still need for improvement in theease and accuracy of such a step.

Still further, because the position of the junction between the coronaryarteries and the aorta is variable, the choice of the location of theplacement of the prosthesis should be as great as possible. The highprofile of many of the finished sewing cuffs of the known devicesseverely limit this choice.

Still further, in many instances, it is advantageous for the surgeon tomove the prosthesis into various positions relative to the sewing cuff.This will allow the valve to sit at the same level, above or below acertain level. For example, it might be advantageous to seat the valvecuff to be seated above the annulus to maximize the effective orificearea. It will be advantageous to be able to place the prosthesis in themost superior position without interference with the coronary arteriesthereby allowing a larger diameter prosthesis to be placed. A lowerprofile cuff allows the surgeon to place the prosthesis as high aspossible without interfering with the coronary artery junction.

Therefore, there is a need for a prosthetic heart valve that has a lowprofile finished cuff whereby the surgeon can have a greater choice inthe superior/inferior placement of the prosthesis valve.

Current prosthetic valves are inefficient because the sewing cuffoccupies part of the area available for flow through the valve. If avery small prosthesis is placed in the annulus, there can be a mismatchbetween the patient's cardiopulmonary requirements and the flow area ofthe valve. If a patient demands a high level of flow due to a largersize, a small sized valve may result in a significant transvalvulargradient. That is, the pressure in the left ventricle is considerablyhigher than the pressure in the aorta. This results in increased workfor the left ventricular muscle and may predispose to myocardialfailure.

If the surgeon suspects that the prosthesis placed is going to be toosmall, he may elect to enlarge the aortic root. Presently, this isaccomplished by opening the aortic annulus opened perpendicular to theplane of the annulus in continuity to the aortomy. The incision isextended along the anterior leaflet of the mitral valve for a varyinglength. A patch of tissue or fabric material is then stitched to thisincision to enlarge it. The procedure allows the insertion of a largerprosthesis into the newly enlarged annulus. However, there is anincreased risk to the patient, principally because of the risk ofbleeding from the suture line. This site is virtually inaccessible torepair after the aorta is closed.

Therefore, there is a need for a simpler way to expand the aorticannulus. Dilation is preferred, and thus, there is a further need to beable to expand the aortic annulus by dilation.

Still further, in minimally invasive surgery, it is sometimes difficultto gain access to a proper fastening plane with a straight instrument.Therefore, it is desirable to be able to use an articulated or curvedshaft for a fastening or stapling instrument. Still further, it is oftendesirable to be able to manipulate the fastening instrument into themost advantageous orientation with respect to the area being stapled.

Therefore, there is a need for a fastening instrument that can beoperated to gain access to a great number of fastening planes.

Still further, it is often desirable to stretch and manipulate anelement prior to fastening that element to the patient. This is notalways possible in minimally invasive techniques using instruments thatare available prior to the instruments disclosed herein. Therefore,there is a need for an instrument that can stretch and shape a flexibleelement prior to and during fastening of that element to a patient in aminimally invasive procedure.

Still further, tough tissue, calcium deposits and the like makefastening an element to a patient difficult, especially in the contextof a minimally invasive technique. Therefore, there is need for aninstrument that can force a staple through tough tissue and/or calciumcovered tissue in a minimally invasive technique. This should beachieved without bunching or damaging the tissue or the element beingstapled.

Often, in minimally invasive surgery, it is difficult to place staplesin precisely proper locations. This is especially true if the staplesare being placed in a circular pattern. Since the circumference of acircle is often not evenly divisible by the width of a staple the gapsbetween staples are often difficult to establish with proper accuracy sogaps in the staple coverage or bunching of either tissue or material isavoided.

Therefore, there is a need for a device that can be used in minimallyinvasive surgery for properly placing staples.

Staple placement can be effected by manually locating the stapledelivery assembly or by automatically locating the staple deliveryassembly. If a manual location technique is used, it is desirable thatthe surgeon be given an opportunity to choose. between a manufacturer'ssuggestion and his own assessment of the situation. Therefore there is aneed for a stapling device for use in minimally invasive surgery thatwill allow a surgeon to manually locate staples or to select a suggestedlocation for the staples.

As above discussed, the placement of staples in a minimally invasivesituation may be difficult to effect in an even manner. Therefore, thereis a need for a means and a method for placing staples in a patternwherein the spacing of the staples is even and no overlap or unwantedgaps occur even if an aorta or other such organ being stapled is an “offsize.” bbb.

Still further, it is desirable that a staple used in a minimallyinvasive surgical technique drive through the tissue and the materialbeing attached to the tissue in a manner that is most effective. Thus,no bunching or gaping should occur, even if the tissue is tough. Theeffort to drive the staple through the tissue should be minimized ifpossible since the mechanical advantage is not the most effective inmany situations.

Therefore, there is a need for a staple that can be used in a minimallyinvasive surgical technique that can be driven through tough tissue inan effective manner.

Still further, there is a need to close the aortomy after completion ofvalve replacement surgery. This is now achieved using sutures. However,this is time consuming. Therefore, there is a need for a means and amethod for closing the aortomy in an efficient and effective manner.

The previous co-pending patent applications, the disclosures of whichare incorporated herein by reference, disclose novel ways to attachheart valve prostheses into human tissue. The present disclosure dealswith more specific areas of the actual fasteners and fastener deploymentmechanisms for accomplishing the fastening methods. As can beappreciated by the teaching of these and this disclosure, the inventionis much more than merely a fastener type or delivery device. Theinvention pertains more broadly to a methodology and system forstretching the prosthesis and annulus, providing a flexible prosthesisanchoring ring and means and devices for deploying the fasteners andfastening the prosthesis to the tissue.

The fasteners disclosed in the co-pending applications are fastenerswhich are formed using a stationary anvil system and a moving driversystem both of which are located on the same side of the prosthesisbeing attached to the patient, and more specifically, inside theprosthesis and the vessel or on the same operative side of the tissue.The need for this type of same-side positioning can be understood fromthe teaching of the incorporated material.

In the case of mitral valve repair, there is no ready access to the backside of the valve which is in a separate chamber of the heart. Moreover,there are more problems besides access that prevent help from outsidethe lumen in a fastener forming process. For example, consider theaortic valve. The annulus of the valve sits at the exit of the leftventricle. The coronary arteries of the heart (left and right) are abovethe annulus. In addition, the aortic annulus is below the junction ofthe vessel wall with the myocardium. To gain access to the back of theannulus, it is required to incise the epicardium. To further complicatematters, the AV node is very close to the aortic annulus.

If one tries to deploy a prosthesis fastening device that uses anoutside anvil or support for forming the fasteners, one encounters manyanatomical and surgical problems. First, for example, the surgeon wouldhave to dissect the coronary arteries from the bed of the heart in orderto “clear” a space below the coronaries to place such a helping tool.This alone would take an enormous amount of time and could be veryrisky. Then, dissection must proceed into the heart muscle in order toobtain direct opposition from within the lowest (inferior) portion ofthe aortic annulus. Therefore, to have a backing device on the outsideof the annulus one must dissect into the myocardium. This would thenrisk intrusion into the AV node and create a very weak area of the heartwhich would need surgical closure when the outside component is removed.

In addition to the above-mentioned anatomical problems, there arenumerous problems associated with mechanics of aligning a fastenerpusher with a forming device located remotely. The tolerances requiredfor alignment are very tight in order of only a few thousandths of aninch outside of which the proper fastener form will not be generated.Compound this with having to split or cantilever a forming member to getit around or under the dissected coronary arteries and it presents atruly monumental task. To further complicate this arrangement as theaorta or lumen size changes the corresponding outside forming membermust accommodate these sizes. This would present a serious problemrequiring many different size devices to accommodate varying sizes ofhuman anatomy. Note also that in some cases, such as AAA procedures,there will be no way to access the outside of the lumen, so the verynature of the procedure requires that the delivery of fasteners berestricted to the inside of the lumen. Thus, prior art devices, otherthan the incorporated devices, have significant drawbacks.

Furthermore, fatigue resistance is an important factor that should beconsidered in placing a prosthesis into a patient, especially if theprosthesis will be exposed to blood flow in a heart. Fluid hammer cancreate significant forces on the prosthesis and any fasteners used toattach it to the patient. If such forces are not properly accounted for,problems can arise. Therefore, there is a need for a fastener placementsystem that can place fasteners in a manner so that fluid hammer and/orfatigue will not create significant problems for the prosthesis.

OBJECTS OF THE INVENTION

It a main object of the present invention is to provide a prosthesisheart valve which can be implanted in a surgical procedure that isminimally invasive.

It is another object of the present invention to provide a prosthesisheart valve that can be implanted in an expeditious surgical procedure.

It is another object of the present invention to provide a prosthesisheart valve that can present the largest possible flow area to thepatient.

It is another object of the present invention to provide a prosthesisheart valve that reduces the number of objects exposed to the patientafter implantation.

It is another object of the present invention to provide a prosthesisheart valve which can be customized to the particular patient withoutplacing undue stress on the patient's tissue.

It is another object of the present invention to provide a prosthesisheart valve which can utilize widely accepted materials while stillrealizing the advantages set forth herein.

It is another object of the present invention to provide a prosthesisheart valve which utilizes a fully flexible sewing cuff.

It is another object of the present invention to provide a prosthesisheart-valve which can use a Dacron sewing cuff.

It is another object of the present invention to provide a prosthesisheart valve which has a finished cuff that has a low profile above thevalve.

It is another object of the present invention to provide a prosthesisheart valve which eliminates suturing as a means for attaching theprosthetic device to the patient.

It is another object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich is minimally invasive.

It is another object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich is minimally invasive yet which is accurate, expeditious andresults in a firmly, accurately and fixedly placed prosthetic device.

It is another object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich reduces the amount of stress that is placed on the patient'stissue during the placement procedure.

It is another object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich does not require opening the patient's chest wall.

It is another object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich attaches the prosthesis valve with fasteners that are hiddeninside the device whereby the chances of infection and thrombosis aresignificantly reduced.

It is a specific object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich hides the fasteners inside the sewing cuff.

It is a specific object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich significantly reduces the chances of the cuff puckering during theimplanting procedure.

It is another specific object of the present invention to provide asurgical technique associated with the implanting of a prosthesis heartvalve which dilates the graft or cuff and the lumen together to provideintimate contact during the fastening procedure.

It is another object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich allows for endoscopic visualization of the placement of the valvein the heart.

It is another object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich permits both dilation and placement of fasteners in a sewing ringor graft.

It is another object of the present invention to provide a surgicaltechnique associated with the implanting of a prosthesis heart valvewhich assures secure attachment of the prosthetic device to the patient.

It is another object of the present invention to permit a surgeon to usea larger valve if such larger valve is indicated.

It is another object of the present invention to provide a means andmethod wherein the annulus of the aorta can be stretched as a prostheticvalve is being placed.

It is another object of the present invention to allow insertion of alarger prosthesis without opening the annulus and adding a patch.

It is another object of the present invention to provide a means and amethod whereby annuloplasty can be performed.

It is another object of the present invention to provide a device thatwill allow the addition of standard sutures to repair or reinforce anyarea of potentially weak attachment of the suture ring to the annulus.

It is another object of the present invention to provide a means and amethod for minimally invasive surgery which can gain at access to aproper fastening plane.

It is another object of the present invention to provide a means and amethod for minimally invasive surgery is able to manipulate thefastening instrument into the most advantageous orientation with respectto the area being stapled.

It is another object of the present invention to provide a means and amethod for minimally invasive surgery which can stretch and manipulatean element prior to fastening that element to the patient.

It is another object of the present invention to provide a means and amethod for minimally invasive surgery that can force a staple throughtough tissue and/or calcium covered tissue in a minimally invasivetechnique without bunching or damaging the tissue or the element beingstapled.

It is another object of the present invention to provide a means and amethod for minimally invasive surgery for properly placing staples.

It is another object of the present invention to provide a means and amethod for minimally invasive surgery that will allow a surgeon tomanually locate staples or to select a suggested location for thestaples.

It is another object of the present invention to provide a means and amethod for minimally invasive surgery that includes a staple that can beused in a minimally invasive surgical technique that can be driventhrough tough tissue in an effective manner.

It is another object of the present invention to provide a means and amethod for minimally invasive surgery for closing an aortomy in anefficient and effective manner.

It is another object of the present invention to provide a fastener thatis self forming, that is a fastener that does not need an anvil tosecure it to a patient's tissue.

It is another object of the present invention to provide a fastener thatis protected from fluid hammer.

It is another object of the present invention to provide a fastener thatcan attach a prosthesis to a patient in a manner such that thedeleterious effects of fastener fatigue are minimized.

It is another object of the present invention to provide a fastener thatcan be used to attach a prosthesis to a patient in a manner such thatthe deleterious effects of a failure of one fastener are minimized.

It is another object of the present invention to provide a fastener thatcan be placed, will approximate tissue, and cinch that tissue all whencontrolled only from one side of the tissue.

It is another object of the present invention to provide a prosthesisfastening system which fastens a flexible prosthesis to human tissuewhich is resistant to the deleterious effects of fatigue.

It is another object of the present invention to provide a prosthesisfastening system which fastens a flexible prosthesis to human tissuewhich has shock absorbing qualities of a non-rigid assembly.

It is another object of the present invention to provide a method toattach a fully flexible prosthesis to tissue with a segmented array offasteners whereby delivery of the fasteners is accomplished entirelyfrom one side of the tissue.

It is another object of the present invention to provide a prosthesisfastening system which utilizes a segmented array of fasteners whichallows for the expansion of the aorta during insertion of the prosthesisin heart surgery,

It is another object of the present invention to provide a prosthesisfastening system which utilizes a fastening element which can grow withthe tissue.

It is another object of the present invention to provide a prosthesisfastening system which utilizes spring-loaded fasteners.

It is another object of the present invention to provide a prosthesisfastening system that utilizes barbed fasteners.

It is another object of the present invention to provide a prosthesisfastening system that utilizes fasteners that are rotationallydelivered.

It is another object of the present invention to provide a prosthesisfastening system which utilizes a segmented array of fasteners whichallows the prosthesis to be flexible, moving in unison to the pulsatingnature of heart tissue loading to resist fatigue of the fasteners usedin heart surgery.

It is another object of the present invention to provide a prosthesisfastening system with the ability to install a fully flexible andexpandable anchoring system which pre-stretches the aorta lumen tissuein heart surgery thereby permitting larger diameter valve to be insertedthan is practical with prior art techniques.

It is another object of the present invention to provide a heart valveprosthesis fastening system with a means of fastening the heartprosthesis all from within a lumen.

It is another object of the present invention to provide a prosthesisfastening system which utilizes a fastening means whereby the fastenersare all hidden from a blood path in heart surgery.

SUMMARY OF THE INVENTION

These, and other, objects are achieved by a sutureless prosthetic heartvalve or graft which has a flexible sewing cuff stapled in place priorto placement of the heart valve body. The objects are also achieved by afastener and a tool and a surgical procedure for effecting placement ofthe prosthetic valve in a minimally invasive manner.

More specifically, the prosthetic valve includes a flexible sewing cuff,such as Dacron, or the like, which is stapled to heart tissue using aspecial tool that is inserted into the patient via an incision locatedin the thorax, either via a retrostenal approach or by removal orseparation of the ribs. The tool releasably carries the cuff andincludes means for continuously pressing the flexible cuff against thepatient's tissue during the stapling procedure whereby the cuff isdeformed rather than the tissue and puckering is essentially eliminated.

The cuff is attached to the valve body using drawstrings which extendoutside the patient's body. The valve body is positioned in the in-situcuff and the drawstrings are operated. Because the cuff is flexible,stretching of the tissue is minimized since inaccuracies are, at least,partially, absorbed by the flexible cuff.

The system disclosed herein should have improved blood flow andbiological acceptance in the patient because suture knots and feltpledgets are not used. This provides additional advantages to use ofthis system due to a potentially reduced risk of stroke and infectionpost-surgery and potential for use of lower doses of anticoagulant andantibiotics post surgery.

Still further, due to the minimally invasive nature of the procedure,there is a possibility of applying the teachings of this invention toemergency procedures that may be performed outside of an operating roomenvironment.

Yet another advantage of the present system is the low profile of thefinished cuff above the valve base. This allows the surgeon greaterchoice in the superior/inferior placement of the valve. This isimportant because the position where the coronary arteries join theaorta is extremely variable. The low profile of the cuff allows for moredistance between the cuff and the coronary junction.

Because the cuff of the present device is formed of material that hasalready been successful and is widely accepted, the commercialadvantages associated with this device are enhanced.

Due to the surgical techniques that can be utilized with the presentinvention, it is possible to use video appliances, such as miniaturevideo endoscopes.

One feature of the present invention is that of fatigue resistance. Inmechanical systems which are subjected to repeated impact or othernon-uniform loading, one needs to design for fatigue resistance. Just asa wire rope is more fatigue resistant than a single rod, the inventorshave taken the approach that multiple small fasteners joined by aflexible member are much better suited to handling repeated loading ofheart pulsation.

In the inventive system, each individual fastener will see only itslocal loading. Each fastener is isolated from adjacent fasteners.Therefore loading on one fastener does not influence the adjacentfasteners with bending moments. The flexing which causes fatigue willhappen between each fastener thereby substantially reducing flexuralloading on individual fasteners, thereby greatly reducing the chances offlex fatigue.

More specifically, the inventive system provides the extra security ofhaving many fasteners in place and the redundancy to back up a failureof any one fastener. Additionally, since individual fasteners make up aperipheral plurality of attachment sites, small gaps between adjacentfasteners are desirable to allow the aortic wall to relax afterinsertion of a prosthesis in heart surgery through normal growth ofminor tissue trauma incidents which will allow for an anchor ring andvalve to essentially “sway with the breeze,” but not become dislodged orleak. The inventive system takes multiple “bites” of tissue to buildeach on the other to create a chain of fasteners that each has apositive grip on the area to tissue within each fastener.

The fastener system of the present invention has several features thatpermits it to overcome the above-discussed problems and to achieve theabove-stated objectives: a plurality of fastening elements spaced in astaggered but uniform pattern; the fastening elements are applied frominside the lumen only without the aid of external anvils or supports;the fasteners penetrate both the prosthesis and the tissue therebyapproximating the prosthesis and the tissue at the individual fasteningelement; and the individual fastening elements can be placed in apattern that allows the lumen and the prosthesis to flex withoutcompromising hemostasis or security.

The presently disclosed means and method can be used to performannuloplasty where the annuloplasty ring is fastened to an aorta above aleaky but salvageable human tricuspid valve. In this form, anannuloplasty ring would be constructed so the cuff material covers amalleable ring whereby the annuloplasty ring is fastened in place withthe disclosed fastener element. The ring could be malleable metal orplastic to allow the surgeon to shape it correctly to impart forces inright area. The malleable ring is then shaped to size or compress theannulus and import a compressive force on the valve causing the leafletsto close more securely. This could be applied to mitral and otherlocations as well.

The placed cuff can be inspected by the surgeon to be sure that it isplaced securely. If the surgeon decides that hand-placed sutures will behelpful, he can place such sutures as needed.

If desirable, the surgeon can use a stable delivery mechanism to placestaples either according to a prescribed path or according to his bestjudgement at the time. The hereinbelow disclosed device includes astaple delivery instrument that can be used to place staples one at atime along a predetermined path, or in conjunction with a guide,automatically along a helical path. The helical path will place staplesin a desired spacing and can be used with staples of different widths.

Still further, the device disclosed herein can be used to close anaortomy. If desired, a surgeon can use the staple delivery device toplace staples along a path set by icons until he becomes more confidentin an automatic placement technique. The instrument saves time inplacing staples.

Yet another form of the stapling instrument delivers staples instaggered rows while being able to engage a cuff to force and stretchthat cuff against the patient's tissue to ensure proper placement of thecuff.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 shows a sectional view of a prior art prosthesis heart valve inplace in a patient.

FIG. 2 is a sectional view of the prosthesis valve of the presentinvention installed in the aortic annulus of a patient.

FIG. 3 is a sectional view of a sutureless cuff used in the presentinvention when the cuff has been stapled to the patient and prior toplacement of the prosthetic valve body.

FIG. 4 is a sectional view of the prosthetic valve of the presentinvention after the cuff has been stapled in place and after theprosthetic valve body has been placed in the cuff and before the cuff isattached to the valve body.

FIG. 5 is an enlarged sectional view of the sutureless prosthetic heartvalve of the present invention with two rows of staples securing thecuff to the patient and the valve base attached to the cuff.

FIGS. 6, 7 and 8 illustrate how the sutureless cuff of the presentinvention is constructed.

FIG. 9 is a side and bottom perspective view of a preferred form of afastener driving tool used in the present invention.

FIG. 10 is an exploded perspective view of the tool shown in FIG. 9.

FIGS. 11, 12, 13 and 14 illustrate the various positions of the stapledriving mechanism during operation of the fastener driving tool of thepresent invention.

FIG. 15 is a sectional view of the fastener driving tool in theassembled condition.

FIG. 16 shows the fastener driving tool in position after the cuff hasbeen stapled to the patient and prior to movement of the valve body intoposition in the in-situ cuff.

FIG. 17 shows the in-situ cuff with the valve body in place prior toattaching the valve body to the cuff.

FIG. 18 shows the cuff attached to the patient and to the valve bodythat has been moved from the FIG. 16 position to the FIG. 17 position.

FIG. 19A illustrates the torso of a patient having the prosthetic valveof the present invention being placed using a fastener driving tool ofthe present invention in a minimally invasive surgical procedureaccording to the teaching of the present invention.

FIG. 19B illustrates the tool inserted into an aorta.

FIG. 20 shows a valve body holding tool inserting a valve body into anin-situ cuff.

FIG. 21 shows an alternative form of the tool having twofastener-delivering heads and which can be used to repair an aneurysm.

FIG. 22 is an exploded section of FIG. 21.

FIG. 23 shows use of the tool shown in FIG. 21 to repair an abdominalaortic aneurysm.

FIG. 24-27 show steps in placing a prosthesis.

FIG. 28 is an exploded perspective view of another form of the toolwhich maintains the handle and shaft stationary during fastenerdelivery.

FIG. 29 illustrates a rotating fastener assembly for use in the toolshown in FIG. 28.

FIG. 30 is an assembled view of the FIG. 28 tool.

FIG. 31 is a perspective view of a staple delivery instrument.

FIG. 32 is an exploded perspective view of a staple delivery assembly.

FIG. 33 is an exploded perspective view of a staple guide means forguiding movement of the staple delivery assembly shown in FIG. 32.

FIGS. 34a-34e and 34a′-34e′ show the steps through which a stapleaccording to the present invention follows as it is being forced intoand through elements to be stapled.

FIG. 35 is an exploded perspective view of another form of stapledelivery assembly in which the assembly is returned to an initialposition by an elastomeric element.

FIG. 36 is a perspective view of another form of staple deliveryinstrument according to the present invention.

FIG. 37 is a perspective view of a head portion of the staple deliveryinstrument shown in FIG. 36.

FIG. 38 is a top plan view of an anchor ring in place in an aortaillustrating how the means of the present invention can stretch the ringagainst the aorta and how the staples of the present invention attachthe ring to the aorta.

FIGS. 39a-39d illustrate the operation of the staple delivery instrumentshown in FIG. 36.

FIGS. 40a-40c further illustrate the operation of the FIG. 36 stapledelivery instrument.

FIG. 41 is a perspective view of another form of a staple deliveryinstrument.

FIG. 42 is staple pattern in a cuff that can be established using theFIG. 41 staple delivery instrument.

FIGS. 43-45 illustrate the steps in placing a heart valve onto a cuffthat has been stapled to a patient's aorta.

FIG. 46 is perspective of another staple delivery instrument.

FIG. 47 is partial view of the FIG. 46 instrument illustrating theangled nature of the staple delivery associated with that instrument.

FIG. 48 shows an anchor ring placement element that can be used with thestaple delivery instrument shown in FIG. 46.

FIG. 49 illustrates multiple rows of staples placed using the stapledelivery instrument shown in FIG. 46 and the anchor ring placementelement shown in FIG. 48 and following a staple pattern established byicons placed on the anchor ring.

FIG. 50A shows a staple pattern established “on the fly” using the FIG.46 staple delivery instrument and the FIG. 48 anchor ring placementelement.

FIG. 51 is a perspective view of an automatic staple placement systemthat uses the staple delivery instrument shown in FIG. 46.

FIG. 52 is an elevational view of the FIG. 51 system showing the FIG. 46tool in place in the system.

FIG. 53 is an exploded perspective partial view of the FIG. 51 system.

FIGS. 54a-54c illustrate helical staple patterns that are establishedusing the staple system shown in FIG. 51.

FIG. 55 illustrates the use of the FIG. 46 tool to close an aortomy.

FIG. 56 illustrates the closed aortomy showing how the staple of thepresent invention brings incised edges together.

FIG. 57 shows one form of self-forming fastener.

FIG. 58 shows a tool element that can be used in connection with thefastener shown in FIG. 57.

FIG. 59 is a side elevational view of the element shown in FIG. 58.

FIG. 60 shows an end of the FIG. 58 element.

FIG. 61 shows another form of self-forming fastener.

FIG. 62 shows a tool element which can be used to place the fastenershown in FIG. 61.

FIG. 63 shows another form of self-forming fastener.

FIG. 64 shows another form of self-forming fastener.

FIG. 65 shows another form of self-forming fastener.

FIG. 66 shows another form of self-forming fastener.

FIG. 67 shows a tool element that can be used to place the self-formingfasteners shown in FIGS. 65 and 66.

FIG. 68 shows the FIG. 67 tool element in an assembled condition.

FIG. 69 shows a tool that can be used in connection with the FIG. 62tool element to place fasteners.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

The invention is a device and method of fastening an aortic valveprosthesis or vascular graft, into living tissue, particularly suitablefor minimally invasive surgery. In the preferred embodiment, the heartvalve is separable from its sewing cuff. The valve body has specialgrooves in its periphery to allow the valve to be attached to the sewingcuff after it has been fastened into the annulus of the patient's aorta.The sewing cuff is specially constructed to provide a means to open upor unfold it and then detachably retain it to the fastener tool to allowfor remote attachment of the cuff deep in the aortic lumen. Once thefasteners have been driven and the cuff is securely attached to theaortic annulus, the cuff attachment means is released and the fastenerdriver tool is removed from the heart. The prosthetic heart valve isthen inserted into the aortic lumen and docked to the cuff. A specialelement is provided between the heart valve body and the cuff to signalto the surgeon when the valve body is properly seated in the in-situcuff. An annular extension spring provides tension to hold the valve inplace. It provides a tactile feedback which indicates to the surgeonthat the valve body is securely attached to the cuff. Once the valvebody is properly seated in the cuff, the cuff is attached to the valvebody with drawstrings or the like. It is noted that while drawstringsare one means for attaching the cuff to the valve body, many othermeans, such as will be known to those skilled in the art based on thisdisclosure, can also be used without departing from the scope of thisdisclosure. Once tightly secured to the valve body, the cuff drawstringsare trimmed thereby completing the installation.

Currently-available valve replacements are hand sewn into the aortaafter surgical removal of the defective valve. A critical component ofthe present invention is that the cuff is fastened to the living tissuewith a series of metal fasteners or staples. The staples are arranged intwo rows and are staggered to ensure a secure fit between the cuff andthe tissue. The fastener driving tool has two stapling mechanisms on twodifferent levels with the staple driving mechanisms on each level beingspaced apart by 105° (see FIG. 11). The staples in each row are set twoat a time, preferably 180° apart in each row, with both rows being atthe same time. The staple mechanisms in one row is off set from thestaple mechanisms in the other row. After forming the two sets ofopposed fasteners, the attachment tool is rotated. This automaticallyindexes to the proper fastener offsets to create two staggered rows offasteners. The offset between staple mechanisms in the two rows ispreferably a 30° index and will provide twelve fasteners per row for a19-21 mm aortic annulus. The fastener driver tool has means to dilatebetween standard size valve bodies. Thus, the same fastener driving toolcan be used on all sizes from 19-23 mm and then the next size up wouldcover ranges from 23-27 mm, the next 27-32 mm and so forth. This is animportant advantage because the surgeon will always want to place thelargest body in the cuff. Presently, if a surgeon chooses a 19 mm valveand finds the cuff to be slightly loose in the annulus, it is a majorexpense to cut loose the 19 mm valve and try again with a 21 mm valve.The fastener driver tool of the present invention may include anindicator that indicates to the surgeon when he is fastening the cuffwhat size valve the annulus has been stretched to, thus eliminatingguesswork.

Referring first to FIG. 1, a prior art prosthetic heart valve H is showninstalled in the annulus of an aorta 1 next to a left ventricle 2. ValveH is secured in place by a series of sutures 14 which are tied in knots13. The sutures are most often used with felt pledgets 15 to spread theload of the sutures evenly so as not to tear the tissue. Valve Hincludes a cuff 3 which is attached to the perimeter of base 12 of valveH in the factory. Drawstrings 9 and 10 are used to effect thisattachment. The cuff and valve body are implanted as a single unit withthe cuff being hand sewn to the tissue. Leaflets 11 are also shown as isthe distance between the top plane of the valve and the right coronaryartery junction with the aorta. This distance is indicated in FIG. 1 bynumeral 6.

Shown in FIG. 2 is a prosthetic valve 7 embodying the present inventioninstalled and seated in the annulus of the left ventricle. Fasteners 23aand 24b are used to fasten sewing cuff 19 to the annulus of the aorta.The fasteners are staples in the preferred form of the invention.Drawstrings 27 and 28 are used to secure the cuff to the body 20 of thevalve, and an indicating means 25, such as a garter spring or the like,is located in the lower section of the cuff. One form of the indicatingmeans includes a garter spring inside a pocket in the cuff. Indicatingmeans 25 is used to signal the surgeon when the heart valve body 20 hasbeen seated properly in the cuff 19 prior to activating the drawstrings.Contact between means 25 and the valve body provides the surgeon with atactile signal that the valve body is properly seated in the in-situcuff.

As can be seen by comparing FIGS. 1 and 2, prosthetic device 7 has nosutures, no pledgets and will be installed as two parts—the cufffollowed by the body; whereas, device H has sutures 14, pledgets 15 andis installed as a single unit. However, as can also be seen, the cuff inboth instances is still securely connected to the valve body and thecuff can remain a flexible material, such as Dacron or the like wherebythe surgeon will still be able to use familiar material. As will bediscussed below, the cuff 19 is totally flexible so it can be deformedto fit the aorta rather than requiring the aorta to be deformed to fitthe valve as is the case with the valve shown in FIG. 1. Still further,the fully flexible nature of the cuff 19 permits easy deformation of thecuff and thus significantly reduces stress on the tissue surrounding theprosthesis. Still further, the fully flexible nature of cuff 19 permitsit to be pressed against the tissue at all times during the installationprocess so the chance of puckering or paravalvular leak paths issignificantly reduced, if not completely eliminated. Using staples inplace of the hand-set sutures of the prior art will, as will beunderstood from the present disclosure, permit the installation of valve7 using a surgical technique that is minimally invasive.

Cuff 19 is shown in place in the aorta prior to placement of the valvebody in FIG. 3. Fasteners 23a and 24b are shown in two rows, withstaples in one row being offset from corresponding staples in the otherrow. Thus, for example, staple 23a′ in the top row corresponds to staple24b′ in the bottom row. The staggered nature of the staples in the tworows causes the cuff to be set by a continuous set of staples if the tworows are viewed together. That is, there is some portion of a fastenerconnecting the cuff to the tissue everywhere in the 360° of thecircumference of the cuff. The two rows of staggered fasteners thusforms a means for connecting of the cuff to the tissue in a continuousmanner about the entire perimeter of the cuff, and eliminates leakpaths.

As shown in FIG. 3, the drawstrings 27 and 28 of valve 7 extend out ofthe cuff for a significant distance. As will be understood from thisdisclosure, these drawstrings have extensions 27′ and 28′ which extendout of the patient's body when the valve is being implanted. Theextensions 27′ and 28′ are connected to the drawstrings 27 and 28 in thecuff which are means for fixedly attaching cuff 19 to body 20, and areactuating means attached to the drawstrings for operating thedrawstrings from outside of the body after the sewing cuff has beenattached to the patient to secure the cuff to the body 20. The prior artvalve has no such drawstring extensions.

A zig-zag drawstring 26 is connected to extension 28′ to be in activatedthereby. Drawstring 26 is sewn from top pouch 28 through the cuff and upagain through the top pouch. When the activating means is activated,drawstring 28′ is pulled and drawstrings 26 and 28 are activated. Whendrawstring 27 is pulled, drawstring 27 is activated and is pulled intorecesses in the body of the valve. The recesses are shown in FIG. 2 at28T and 27B respectively. FIG. 4 illustrates how the cuff will be drawninto the recesses of the valve body during this cinching procedure. Inthe FIG. 4 condition, the top cords have not yet been seated. When thecords are pulled tight and cinched up the zig zag drawstring willautomatically pull the top cords down into the top recess. Furthertightening will cinch the cords tight into the recesses. Aftertightening, knots can be defined in the cords to secure the means 27′and 28′. FIG. 5 shows the prosthesis after it has been set and the cuffattached to the body.

The sutureless cuff 19 is shown in FIGS. 6, 7 and 8. This cuff can beexpanded for sizing. As shown in FIG. 6, the cuff is formed of a single,unitary tubular piece of fabric 18 which is folded over at location 21to form an inner layer 19I and an outer layer 190, with top cord 28 andbottom cord 27 being located at corners in the fabric. Cord 27 isadjacent to guide means 25. As shown in FIG. 7, stitching 29 and 31create drawstring pouches 27P and 28P. A final suture stitch 30 is shownin FIG. 8 completes the cuff.

A tool T for placing the cuff in the patient and for applying thefasteners to attach the cuff to the patient is shown in FIGS. 9-16. Thistool can be inserted into the patient to initially place the cuff inposition, and to set the fasteners to attach the cuff. The tool isoperated from outside the patient's body so the overall procedure isminimally invasive.

Tool T broadly includes an operating handle 35 and a fastener deploymentknob 36 on one end of a body 33 which can be curved if desired. Anoperating head 37 is on the other end of body 33. Anchor means 28a″ arelocated adjacent to handle 35 and releasably attach the activating means28′ to the tool so these activating means are located outside of apatient's body during the cuff attaching procedure. As will beunderstood from the teaching of this disclosure, once the cuff isattached to the patient and the valve body is in place, the activatingmeans are released from the tool and are operated to attach the cuff tothe body. For the sake of clarity, the activating means are shown inFIG. 9 released from the tool. It is also noted that there will be asleeve on the shaft to keep the drawstrings from winding up on theshaft. Alternatively, the drawstrings can extend through the center ofthe shaft or held in a coiled at the bottom of the tool.

Suture stays 32 (see FIG. 9) are attached to the tool head 37, and thecuff is stretched over the head 37. The temporary suture stays 32 aredrawn over the distal and proximal ends in order to secure the cuff tothe head 37 during placement into the patient's body. The temporarysuture stays 32 are tied to post 34 so that once the fasteners aredeployed, the suture stays 32 can be cut to release the cuff 19 from thehead 37 to help the surgeon with alignment of the body 20. The stays 32act as a hammock or safety net to prevent the body 20 from being placedtoo low in the cuff which would result in the misalignment of lowerdrawstring 27 into the lower recess 27B. As deployment knob 36 is turnedin a clockwise direction, each half revolution of the knob delivers twopairs of fasteners through the cuff. During that rotation, the latterpart of the handle movement indexes head 37 inside the cuff 19staggering the next pair of fasteners to be delivered. Drawstringactivating means 28′ is fed up along the shaft of the tool T to theholding cleats 28a″ and are removed from this cleat, allowing tool T tobe removed from the patient. Activation means 27′ is retained coiled atthe bottom of the instrument. The means 27′ will be played out as thetool is removed from the patient whereby this means 27′ will also belocated outside the patient for activation.

The tool T has several functions. One function is to insert the cuffinto the patient, another is to position the cuff in the patient,another is to fasten the cuff to the patient, and yet another is to holdthe cuff securely against the patient's tissue during the fasteningprocedure. This last function is performed as a dilation and spreadingprocedure as will be understood from the teaching of this disclosure.

Referring to FIG. 10, head 37 of tool T is shown as including a housing50 which includes two sections, upper housing 52 and lower housing 54both of which are attached to a hexagonal shaped drive shaft 56 andwhich are attached together by fasteners, such as screws 57. Drive shaft56 is operatively connected to operating handle 36 to be rotatedthereby. The housing sections are slidably connected to index rings 58and 60 respectively and the cuff is connected to the index rings. Aswill be explained below, the housings are rotated during the fasteningprocedure, but the index rings remain stationary with, respect to thehousing so the cuff will remain stationary with respect to the housing.The index rings fit into grooves, such as groove 64, to be slidablyconnected to the housing sections. Upper housing 52 includes an anchorpin 66.

Also fixedly attached to the housing is a driver head plate 68 so thatplate rotates with the housing. Plate 68 includes a top surface 70 and abottom surface 72. Two identical fastener driver accommodating slots aredefined on each surface of the driver head plate. These slots areidentified in FIG. 10 by the reference numerals 80, 82, 84 and 86 andeach extends radially of the plate. The slots are arranged so that topsurface-located slots 80 and 82 are offset from each other by 180°, andbottom surface located slots are offset from each other by 180°, withthe top surface-located slots being offset from the bottom surfacelocated slots by 105°. After each fastener is set, the tool is rotatedby 30° whereby the above-discussed stagger is established for thefasteners. The indexing of the head is achieved by movement of thehandle 36 which is attached to a visually indicating means whereby asurgeon can keep track of where the fasteners are being set.

A cam means is located inside the housing. The cam means includes twocam plates, 86 and 88. The cam plates are identical, therefore, only onewill be described. Cam plate 86 includes a top surface 90 and has ahexagonal hole 92 defined therethrough to attach the cam plate to driveshaft 56 for rotation therewith. An anti-retrograde means is included oncam plate 86 for preventing the cam plate from rotating in an undesireddirection. Rotation in an undesired direction may interfere with thefirm placement of the fasteners. The anti-retrograde means includescleats 94 which are engaged by a one-way prong which permits rotation ofthe cam plate in one direction only. A second larger set of index lugs95 can be provided to give feedback to the surgeon at the end of thefastener cycle. Index gear teeth 96 are defined on the outer peripheraledge of the cam plate and are operatively connected to index gear teeth98 on the index ring 58 in a manner that rotates index ring 58 in adirection opposite to the direction of housing rotation at the same rateof rotation whereby the index ring remains stationary with respect tothe patient as the housing rotates. This operation keeps the cuff, whichis attached to the index ring, stationary with respect to the patient.Gears 96 and 98 are operatively coupled together by pinion 100 that ismounted at one end thereof on driver head plate 68 and at the other endthereof to the housing section 52, 54. Pinion 100 has a first gear teeth102 engaging teeth 96 and second gear teeth 104 engaging gear. teeth 98for transmitting rotation of the cam plate to the index ring. Eachpinion has a waist section 105 that is received in a pinion slot 107defined in driver plate 68.

A cam 106 is mounted on surface 108 of cam plate 90 and has anelastomeric band 110 thereon. The cam 106 is shown in FIGS. 10-12 androtates with the cam plate. The cam has two lobes, 112 and 114 spacedapart by 180° as well as a groove 116 defined therein for a purpose thatwill be understood from the ensuing disclosure. The cams are rotatedwith respect to the driver head plate 68 whereby each cam lobe passeseach slot 80 and 82 once each revolution of the drive shaft 56. As willbe understood, each revolution of drive shaft 56 thus drives twofasteners from the top surface of driver plate and two fasteners fromthe bottom of the driver plate. In this manner, even pressure is placedon the cuff and tissue during each fastener driving step because theslots are offset from each other by 180° on each surface of the driverplate. This keeps the cuff and tissue from puckering due to unbalancedfastener driving forces.

Each of the slots 80, 82, 84 and 86 has a fastener driver mechanism 120accommodated therein. All of the fastener driver mechanisms areidentical, therefore, only one mechanism 120 will be described.Mechanism 120 includes an anvil 122 mounted on driver plate 68 to slidethereon, with movement of the anvil in a direction that is longitudinalwith respect to the anvil being radial with respect to the driver plate.The anvil includes a pin 124 that is slidably received in groove 116defined in the cam so the anvil is moved into and out of the slot as thecam rotates. This anvil movement is timed so fasteners can be drivenwithout jamming. A lifter spring 130 is mounted under the driver plateto remain stationary on that plate whereby the anvil moves with respectto the lifter spring. A driver 144 is slidably mounted in the slot andis attached to the cam lobe by ring 110 engaging both the cam lobe and arider 111. The driver moves radially of the driver plate and is heldagainst chordal movement with respect to that driver plate. Therefore,rotation of the cam plate moves the driver 144 radially inwardly andradially outwardly with respect to plate 68. The groove 116 is formed sothat driver and anvil movements are in timed relation to each other. Thedriver includes two fastener-engaging tips 140 and 142 which areseparated by a U-shaped opening 144 having an anvil-receiving notch 146located therein.

A stack 148 of fasteners, such as staple 150, is contained in thehousing to feed fasteners between the driver head and the anvil in amanner that is timed to place a fastener in driving position prior tothe driver head moving radially outward in a fastener driving movement.Opening 144 is sized and shaped so that lifter spring 130 moves a drivenfastener off of the anvil prior to the anvil moving arcuately away fromthe driving location and prior to a new fastener moving into the drivingposition between the driver and the anvil. A stack spring 152 isanchored to the housing section 52 by projection 66 and maintains forceon the fasteners that is directed to feeding fasteners to afastener-setting location after a previous fastener has been driventhrough the cuff and into the tissue. The anvil folds the fastener in amanner such that the sharp points 162 of the fastener drive directlythrough the cuff and the tissue rather than tear through the cuff andtissue. The anvil then folds the fastener after that fastener haspierced the cuff and the tissue to establish the closed fastener. Eachstack spring also has an anti-retrograde spring 166 thereon. Spring 166engages cleats 94 on the cam to prevent the cam from moving in anundesired retrograde direction. Fasteners are retained into the housingvia recesses or doors, such as pocket 170. Each stack spring 152 alsohas two wings 167 that engage slots 168 defined in the driver plate tomaintain the stack spring in the proper orientation and position to feedthe fasteners, yet which will permit the stack spring to be removed viathe door 170 to load fasteners. However, the preferred form of the toolis disposable.

As above discussed, it is a significant advantage of the tool T that thecuff is maintained in contact with the tissue during the fastenersetting procedure. This advantage is realized by means of cuff dilationmeans, such as spring 172, mounted on the driver plate and extendingradially outward from the outer peripheral edge of that driver plate.The springs curve gently outward and inward in a U shape to gentlyengage the cuff from the inside of that cuff and gently urge it againstthe tissue. The springs are mounted on the driver plate byspring-receiving slots, such as slot 174, defined in the outerperipheral edge of the driver plate so the spring is maintained on theplate and in the desired orientation.

For purposes of clarity, four positions of the fastener driver mechanismare shown in FIGS. 11, 12, 13 and 14. Beginning a cycle, a fastener hasbeen driven through the cuff and the adjacent tissue, and is formed inFIG. 11 when the driver forces the fastener against the anvil. As thedrive shaft is further rotated, the cam lobe moves from the FIG. 11position to a retracted position shown in FIG. 12, with the anvil beingpulled back after the set fastener has been pushed off that anvil by thelifter spring 130. Continued rotation of the drive shaft rotates the camlobe into a loading position shown in FIG. 13 during which time, a newfastener is fed between the anvil and the driver. Further rotation ofthe drive shaft rotates the cam into an advance position shown in FIG.14 which forces the driver against the fastener and the fastener throughthe cuff and the tissue.

Once all of the fasteners have been set, sutures 32 are unfastened fromthe cleat 34 on the body 33, cut and loosened to permit the tool to beremoved from the patient. Then means 28′ is removed from the cleat onthe tool. Then, tool 85 is removed from the patient which plays outactivating means 27′ to the outside of the patient. A prosthetic valvebody 20 is then inserted into the patient using a tool T′ shown in FIG.20, and is placed in position adjacent to the cuff. The valve body ismoved until the surgeon is notified by the indicating means that thebody is in the desired orientation. The activating means 27′ and 28′ arethen activated to pull the cuff over and against the body by theabove-discussed action of the drawstrings. Once the drawstrings areoperated and the cuff is held tightly against the body 20, theactivating means can be severed and removed from the patient. Theprosthetic valve is now in place. Any tools can be removed from thepatient and closure can be effected. As above discussed, the fastenerswill be continuous over the entire perimeter of the cuff thereby furtherensuring that no leak paths will develop. The continuous nature of thefastener coverage is best understood by visualizing a unit vector UV asshown in FIGS. 3 and 4, which is centered at the center of the cuff andbeing two rows thick, that is having a thickness indicated in FIGS. 3and 4 by dimension t_(v). As this unit vector moves through 360°, itwill never be out of contact with a fastener whereby the entirecircumference of the cuff is fastened to the tissue. The horizontalorientation of the fasteners further contributes to this feature.

As shown in FIG. 20, tool 85 includes a handle 162 and a pair of legs164 which are spread apart by screwing handle 162 into the bottom of aholding fixture 164, forcing tapered edge 166 into the legs. The valvemay then be inserted down into the cuff 19 until the garter spring 25 inthe cuff is felt to detent into the lower recess 27B indicating properseating of the valve body in the cuff.

An alternative form of the tool is shown in FIGS. 16-18 and maintainscontact between the tool and the cuff whereby the cuff can be invertedafter the valve body has been moved into position. The valve body isattached to the tool and to the cuff during fastening of the cuff to thetissue. After completion of the fastening step, the valve is pulled upthereby inverting the lower section of the cuff. The drawstrings arethen cinched as above described.

As above discussed, the central shaft experiences a counter-rotation asthe driving head is indexed so the cuff is held stationary with respectto the patient's tissue while the fastener head is being indexed to thevarious positions. A further alternative form of the tool is shown inFIGS. 28 and 30 at T′ and keeps the handle and the shaft stationarywhile the fastener delivery system rotates. A rotating fastener assembly300 is shown in FIG. 29. Tool T′ includes mechanisms necessary todeliver the fasteners and which are located inside the central shaft. Alever 400 actuates the mechanisms from within the housing. A centralbore 402 is defined in the housing of the tool and has a centralretaining stalk 404 therein on which the distal end 406 of the sewingcuff 19 is located. The heart valve base can also be attached to thestalk end 406 if the base is attached to the cuff 19 prior to settingthe fasteners. The cuff is temporally attached to the outer housing 408and the stalk 404 which remain stationary during the fastening procedureand the fasteners are delivered in a coaxial method from between twostationary parts. Within the central fastener delivery assembly 300 arecomponents similar to the above-described cam mechanisms needed to drivestaples through the cuff and form them in the annular tissue fromwithin. As above described, driver mechanisms 301 are diametricallyopposed and offset with respect to each other to create the appropriateoverlapping staple spacing discussed above. Staggering allows twodistinct rows of staples to be formed as above discussed whereby totalcoverage of the cuff is effected. Toggle links 303 are used and areconnected to longitudinal drive rods 305. Drive rods 305 translatehandle-generated forces into fastener delivery forces at the togglelinks 303. Each toggle link 303 is connected to a staple driver 307. Thefastener assembly 300 is rotated a plurality of times to form the tworows of staples. Flexible shafts (not shown) can also be used to permitthe driving angle of the fasteners to be altered as necessary. Flexibleshafts can also be used to permit the tool to operate to drive fastenersfrom the superior to inferior side of a suture cuff which might bepre-attached to the valve body. Such a cuff could be temporarily tied tothe stationary housing. Upon insertion of the valve, cuff and instrumentwould be inserted into the annulus. Each fastener would form from thesuperior side of the cuff penetrating the cuff and annular tissue below.Again, as above discussed, one or more complete rows of fasteners wouldbe formed holding the cuff to the annular tissue.

A balloon B (see FIG. 24) is used as a means for anchoring andpositioning. Balloon B can either be attached to the fastener drivingdevice or be separate. The balloon can be inflated using a hand pump HB.The balloon is pulled up snugly under the annular tissue and the deviceis brought down to it. Then, the tool can be drawn up close to theballoon trapping the annular tissue and aligning the tool for formingfasteners.

A second method (see FIG. 25) uses levers 450 and links 452 to deploysmall flanges 454 around the lower periphery of the lower housing 54. Byactuating a central rod 456, the connecting links pivot the flangesoutwardly providing a lip in which the surgeon can draw the tool upwardlocating the staples in the proper location in relation to the annulartissue.

A third method (see FIG. 26) uses a clear cylindrical sizing tool 460which uses a lip 462 or flange that sits on top of the annular tissue464. It also has a special tissue marker mounted on a central shaft 466.The surgeon will visualize the contact of the annular tissue from above.The contact with the surface will create a wetted dark circle whenproperly seated on the annulus. At that point, the surgeon rotates thecentral shaft 466 which creates a line 468 inside the aorta. This linewould have a distance D (FIG. 26) that would correspond to a pointer orlandmark to be used to line up the device in the correct position.

Still another way (see FIG. 27) to gauge the placement of the device isto drive sutures 470 below the annulus to create a safety net 472 thatwill not allow the device to plunge too deeply into the left ventricle2. The device is then inserted until the resistance of the suture net isfelt by the surgeon. Once the cuff is fastened into the annulus, thesutures can be cut and removed from the annulus.

In the interest of completeness, an open thoracotomy surgical techniquefor aortic valve replacement will now be discussed (see FIGS. 19A and19B). A surgical incision 200 is made in one of several locations: amidline sternotomy incision; or a small anterior right or leftthoracotomy; or a mini-thoracotomy (with or without rib removal); or aposterior thoracotomy; or a suprasternal or supraclavicular approach; orthrough port sites (mini incisions) over the chest wall. The pericardiumis then opened. The patient is then placed on cardiopulmonary bypassusing: right atrial cannulation; or femoral vein-femoral artery; orfemoral artery-left atrium; or aortic-left atrial cannulation. The aortais dissected for access and clamping. The aorta is then crossclamped andcardioplegia is delivered through: the aorta, coronary ostialcannulation or retrograde through the coronary sinus to arrest theheart. A venting device is then inserted.

The aortomy is then performed. The aortic valve is excised and theannulus, aorta and/or the anterior leaflet of the mitral valve, andseptum are debrided as necessary and appropriate. A device or devicesthat determine the relative size of the annulus and that identify theposition of the staples and stapling device, is inserted into theannulus. When appropriate, sizing and positioning are determined, abiologic marker is circumferentially traced over the top (most superior)edge of the position/sizing device, to guide the proper placement of thestapling device. A balloon or levers can also be used.

The position/sizing device is then removed and the stapling device isinserted and positioned in the annulus with the cuff of the valve. Thestapling device is positioned with the cuff lying in the annulus and theposition confirmed by its proximity to the circle previously marked. Thestapling device is enabled to dilate the annulus with the valve cuff insitu.

The stapling device is then actuated. The appropriate size of mechanicalvalve skeleton is then inserted into the cuff. The valve and theperivalvular area are tested for proper size and the device is removed.Once the proper size is established, the skeleton is removed and thevalve base is inserted. The drawstings of the cuff are then tightenedand tied securely to trap the mechanical valve to the cuff. This assuresthat the largest desirable valve base will be used. The aortomy isclosed with traditional sutures or with vascular staples. The heart isde-aired and the crossclamp removed. The patient is then removed fromcardiopulmonary bypass and the wounds are closed.

An alternative technique with the valve pre-attached includes thefollowing steps. All methods up to and including placement of thebiologic marker circumferentially over the top edge of theposition/sizing device are repeated. Then, the position/sizing device isremoved. The stapling device already pre-attached to a mechanical ortissue valve of appropriate size is lowered into the annulus. Thestapling device and the cuff of the valve are positioned in theappropriate place in the annulus using the biological marker circlepreviously marked on the aortic wall for verification. The cuff-valveborder at this time would be found in a slight subannular position.

The stapling device is then actuated. The drawstrings in the cuff of thevalve are drawn and tied securely to bring the valve in proximity to theannulus. The remainder of the steps are the same as above described.

Yet a third technique for aortic valve replacement is through the leftatrium. This technique includes the following steps: surgical incisionsare made in the manner discussed above; the pericardium is opened; thepatient may or may not then be placed on cardiopulmonary bypass. Thetechnique then includes the use of imaging devices (both intra andextra-vascular) being used to guide the conduct of the operation. Pursestring sutures (access) are then placed on the left atrium and aorta.Flexible imaging devices and instrumentation is then inserted throughthe left atrium (and aorta). The devices are lead through the mitralvalve and into the left ventricle. The aortic valve is then imaged boththrough the aorta and left ventricle and is excised.

The valve stapling device is then inserted through the left atrium andpositioned in the aortic annulus. The stapling device is then activatedand positioning assessed both through the left ventricle and aorta usingthe imaging devices. The stapling device is then removed, and allcannulation sites secured. The heart is then deaired and taken offcardiopulmonary bypass if appropriate. The wounds are then closed.

A minimally invasive surgical procedure is illustrated in FIGS. 19A and19B. A torso with an overlapping rib cage is shown. Access to the aortais gained through an incision 200 in the superstenal notch passing belowthe manubrium or via a mini-thoracotomy is performed in the area of thefirst and second ribs enabling visualization of the aorta. A smallincision 202 across the aorta above the annulus is made. The fastenerdriving tool T with attached is inserted through the incision after thefaulty valve has been excised. The knob 36 is rotated while holding thehandle 35 to deploy the fasteners through the cuff 19 and into theaortic annulus. Once the fasteners have been driven into the aorticannulus, the stay sutures 32 are removed from cleat 34 allowing the headof the instrument to be removed from the patient's body. Activatingmeans 27′ and 28′ are also removed from the cleats 27a″ and 28a″. Theheart valve body is then placed into a holding fixture, such as theabove-discussed fixture, and inserted into the aortic annulus in thesame manner as the tool T. The valve body is then docked into the sewingcuff 19. The indicating means provides tactile feedback for the surgeonto determine when the heart valve body 20 is properly seated. Temporarystays 32 prevent the heart valve base from descending too far andaligning the drawstrings with the recesses in the valve body. Once thelower drawsting has been cinched up, the upper drawsting is pulledtight. The zig-zag drawstring 26 will then pull the cords into the toprecess 28T.

As shown in FIGS. 21-23, the system can be used to repair an abdominalaortic aneurysm (AAA) which may occur because of a thinning of theaortic wall 250. The wall balloons out under positive pressure and formsa pouch 252. These aneurysms present life-threatening consequences forthe patient should they rupture. If detected prior to rupture, a graft254 can be placed on the aorta, in an abdominal graft procedure toprovide support to the weakened area of the wall. The graft is usuallymade from a tube of Dacron fabric and is most often sutured in place.

However, using the teaching of the present invention, the graft can bestapled in place. As shown in FIGS. 21 and 22, the dilating fastenerdeployment feature of the present invention permits fasteners to beformed from the inside toward the outside of the aortic wall. As shownin FIG. 21, the fastener deployment device has two driving heads 260 todeliver fasteners through the graft on either side of the aneurysm 252.At each end of the graft in FIG. 22 there is a metal ring 266, analogousto the garter spring discussed above. These rings help to keep the graftopen once it is fastened to the aortic wall. FIG. 23 illustrates accessto the aorta gained through entry in the femoral artery in the pelvicregion. The fastener deployment device, with graft attached, would beinserted into the femoral artery and fed up to the area of the aneurysm.The distal head 260 is positioned beyond the aneurysm and the proximalhead 260 is positioned to center the aneurysm underneath the graft.Fasteners are formed in a manner similar to that discussed above,completing the installation of the graft. Stay sutures may be used tohold the graft in place during fastening.

During the installation of the fastener driving device, it will beimportant to obtain the correct anatomical positioning of the cuff to befastened to the annular tissue. FIGS. 24-27 depict four different waysto accomplish this task. FIG. 24 shows the use of an inflatable balloonB in the left ventricle 2.

As discussed above, there are times when a surgeon wishes to use anarticulated or curved shaft to accommodate anatomical positioning of theinstrument. As also discussed above, a curved shaft may be particularlyadvantageous in minimally invasive surgery where access to the properfastening plane may be difficult or impossible with an instrument havinga straight shaft. In such a case, instrument 600 shown in FIGS. 31, 36and 37 is used to drive fasteners or staples radially outwardly. Theadvantage of the radial design is that it simplifies the delivery oflongitudinal forces through the shaft of the instrument.

Referring to FIG. 31, it is seen that instrument 600 includes proximalend 602 that will be located outside the patient and which will beoperated by the surgeon. Instrument 600 also includes a distal end 604which will be located inside the patient and to which the cuff 19 willbe attached and to which the heart valve 20 will be attached. A housing608 can be articulated or flexible so the overall instrument can be bentas needed. Proximal end 602 contains an index mechanism 610 and a handwheel 612.

As can be seen in FIGS. 31 and 41, a pre-fire rod 614 includes a handle616 and a body 618 which is accommodated in a bore 622 defined throughhand wheel 612 and through housing 608 to have its distal end 620located near distal end 604 of the housing for a purpose that will beunderstood from the ensuing discussion. As will be understood, there arealigned bores in instrument 600 so pre-fire rod 614 will extend throughinstrument 600 from proximal end 602 thereof to distal end 604 thereof.

Index mechanism 610 includes a bracket 624 which is held stationary withrespect to the patient during an operation. Bracket 624 is U-shaped andhas two legs 626 which are connected together by a central leg 628. Anindex alignment plate 630 is attached to the distal ends of the legs 626and includes a plurality of angularly spaced apart index alignmentholes, such as hole 632. Housing 608 is attached to surface 634 of theindex alignment plate 630. Holes 632 are spaced apart a predeterminedangular spacing as determined by the needs of a surgeon as will beunderstood by one skilled in the art based on the teaching of thisdisclosure.

Two index pins, such as pin 638, are mounted on a lower surface 640 of awedge cam driver plate 642 which has an upper surface 644. Plate 642 isrotatable with respect to plate 630 whereby index pins 638 can be movedfrom one index hole 632 to another index hole. Two wedge cams 646 and648 are each attached at one end thereof to the driver plate 642 torotate therewith and each has a wedge shaped distal end 650 and 652respectively. Each distal end 650 and 652 has a terminal end, such asend 654 of end 648 and a surface, such as surface 656 of end 648, thatslopes outwardly from end 654 along the longitudinal direction towardproximal end 602. As driver plate 642 is moved in longitudinaldirections 660 and 662, ends 648 and 650 are moved in correspondingdirections. The purpose of this movement will be understood from theensuing discussion. Each of the wedge cams includes an inner edge 664and 666 that is spaced apart from the corresponding inner edge of theother wedge cam so that a gap 668 is defined therebetween. Pre-fire rod614 is accommodated in gap 668 so that distal end 620 of the pre-firerod is located adjacent to ends 654 of the wedge cam bodies.

The pre-fire rod is forced in directions 660 and 662 by moving handle616 in the desired direction. Wedge cams 646 and 648 are also moved indirections 660 and 662 by movement of driver plate 642. Driver plate 642is moved by turning hand wheel 622 in directions 670 and 672. A threadedshaft 674 is attached to hand wheel 612 to be rotated thereby andincludes a distal end connected to driver plate 642. Shaft 674 isthreadably accommodated in leg 628 of the bracket 624 to move indirections 660 and 662 in response to the rotational movement of thehand wheel 612 in directions 670 and 672. Shaft 674 is coupled to driverplate 642 to move that plate in directions 660 and 662 but to rotaterelative to the plate so the plate does not rotate with the hand wheel.A suitable de-coupling joint is used to effect the connection betweenshaft 674 and plate 642.

Operation of the fastening tool described thus far is understood fromFIG. 41. Thus, the wedge cam sloping surfaces 652 are oriented bydisengaging index pins 638 from alignment holes 632, rotating driverplate 642 until the index pins are aligned with the selected holes, andthen operating hand wheel 612 to move in direction 660 until the indexpins are suitably seated in the selected index holes. Pre-fire rod 614is then forced through the longitudinal bore until distal end 620thereof is suitably positioned. Further operation of either the pre-firerod or the hand wheel will operate the fastener mechanism as will bedescribed below.

As discussed above, the staple mechanism includes a plurality of stapleassemblies 680 that are angularly spaced apart as shown in FIG. 36. Thestaple assemblies are also located in two rows that are spaced apartlongitudinally of the instrument as indicated by rows R1 and R2. Theassemblies are also offset so staples in row R1 are staggered withrespect to staples in row R2.

The assemblies are all identical therefore only one assembly will bedescribed. As shown in FIG. 32, assembly 680 includes an anvil frame 682having a base section 684 having sides 686 and 687 each having an innersurface 688 and 689 to define a cavity CA therebetween. A center anvil690 is located centrally between the sides and extends upwardly abovebase surface 692. A lifter spring 694 is H-shaped and includes aU-shaped front end 696 with two legs 698 and 700 extending therefrom.Spring tabs 702 are located on the other end of each leg. The lifterspring is curved so front end 696 curves upwardly from base surface 692when the lifter spring is seated thereon. Spring tabs 702 engage theanvil frame to hold the spring in place in the cavity CA. End 696 willbe located adjacent to center anvil 690.

A driver 704 is wedge shaped and is received in cavity CA. Driver 704includes a front edge 706 having two surfaces 708 and 710 thereon with adriver stop 712 on an undersurface thereof. The legs 708 and 710 will belocated adjacent to center anvil 690 when the driver completes afastener driving step as will be understood from the followingdiscussion. An engaging element 714 extends rearwardly from the driver704 and includes a hook 716 for engaging a corresponding groove 717 (seeFIG. 33) defined in each of the wedge cams.

A W-shaped staple 720 is received in cavity CA and includes two legs 722and 724, each having a sharp tip, such as tip 726 that is forced throughthe patient's tissue and through the cuff. The staple further includes adoubly curved center section 730 having a first curve 732 and 734connecting each leg to the center section and a central curve 736. Thecentral curve 730 is located to be engaged by center anvil 690 when thestaple is forced in direction 732 by driver 704 engaging curves 732 and734. Legs 722 and 724 slidably engage surfaces 688 and 689 to be heldstraight during the movement in direction 732 until the legs leave theanvil frame. Legs 722 and 724 are parallel and pierce the article beingstapled before they are folded over through contact of the section 736with center anvil 690.

As can be understood from the foregoing, as staple 720 is forced indirection 732, legs 722 and 724 move in direction 732 in slidingengagement with surfaces 688 and 689. After staple center section 736engages center anvil 690, further movement in direction 732 causes thelegs 722 and 724 to fold towards each other until they overlap eachother. This is a two step movement of the staple: a first linearmovement of the legs; and then a folding over of the legs. The firstlinear movement causes the legs to push through the tissue and thematerial of the cuff in a linear direction before the legs are foldedover. Thus, the staple can take a significant bite our of the materialan the tissue before folding. This is helpful if the tissue is hard oris covered with calcium.

The staple disclosed herein is narrow in its preform width and canresist gathering of the cuff and tissue during the forming process.Staple designs such as box staples gather and bunch material between thelegs of the staples as they are formed. Bunching is inconsistent withthe needs of this device. If a staple bunches, far too much material inthe cuff is used (gathered) and by the time the staple pattern comesaround to making a full circumferential line, the fabric is too tightand can pull away from the aorta wall.

Return movement of the assembly is indicated in FIG. 32 by arrow 732′,and is caused by hook 716 being engaged in groove 717. The groove issloped so that as the wedge cam is moved in direction 660, the driver ismoved in direction 732, and as the wedge cam is moved in direction 662,the driver is moved in direction 732′.

An alternative form of the assembly is shown in FIG. 35 as assembly680′. Assembly 680′ is similar to assembly 680 except driver 704′includes a rear projection 734 and two forward projections 708′ and 710′which engage curves 732 and 734 of the staple to drive the staple asdescribed above. Assembly 680′ includes a U-shaped lifter spring 702′which has two legs 698′ and 700′ with tabs 702′ for engaging recesses703 to hold the spring in the anvil frame. Assembly 680′ is moved indirection 732 in the same manner as assembly 680, but includes a post740 on top of a frame plate 742 that is fixed to the anvil frame. Agarter spring 744 (see also FIG. 36) or the like is wrapped around theposts of the assemblies 680 to return them in direction 732′. Operationof assembly 680′ is similar to the above-described operation of assembly680.

Operation of the staple is illustrated in FIGS. 34a-34e for assembly 680and in FIGS. 34a′-34e′ for assembly 680. Thus, FIG. 34a shows a staplein a nested position, FIG. 34b shows the first step in which the legs ofthe staple are pushed linearly out of the anvil frame to advance thestaple, FIG. 34C shows the crown or central curve engaging the centeranvil to initiate the folding of the legs, FIG. 34D shows the legs beingfolded over and FIG. 34E shows the staple in its final form.

Operation of the instrument can be understood from FIGS. 36, 37, 38,39a-39d, and 40A-40C. As shown, a wedge cam body 750 is slidablyreceived in housing 608 and has wedge cams 646 and 648 thereon. Thewedge cams are inserted into a wedge cam alignment block 752 via slots,such as slot 754. The wedge cam alignment block 752 is fixed to a head756 by fasteners, such as threaded bolt 758. Head 756 contains all ofthe above-described assemblies 680 or 680′ in staggered rows R1 and R2.

Wedge cam driver plate 642 is moved in direction 662 to release indexpins 638 from index alignment holes 632 which moves the wedge cams outof the slots 754. The driver plate 642 is then rotated in direction 670or direction 672 to align index pins 638 with new index alignment holesand thus align the wedge cams with new slots.

Hand wheel 612 is then rotated to drive plate 642 in direction 660 toset the wedge cams in the slots near the rear ends of the stapledrivers. Pre-fire rod 614 is then driven down in direction 660 to moveanvil frames radially outward into a pre-fire position, such as shownfor staple 720′ in FIG. 36 which drives the staple through the cuffmaterial and through the tissue. A frame stop 760 is located on thebottom of each anvil frame and engages a corresponding shoulder in theinstrument to stop movement of the anvil frame in direction 732 when theprefire rod moves past the anvil frame. Hand wheel 612 is then operatedto drive the wedge cams in direction 660 which drives the staples indirection 732. This drives the staple through the cuff and through thetissue and folds the staple legs over as above discussed. The lifterspring then moves the folded staple over the center anvil 690 to releasethe staple from the assembly. A plurality of staples are stored in theinstrument so another staple is ready for deployment as soon as theoperation is complete.

The hand wheel is then rotated in the opposite direction, the pre-firerod moved in the opposite direction, and the staple assembly is movedback into its rest position.

Operation of the instrument is shown in FIGS. 39a-39d and 40A-40C. Theresults of the operation are indicated in FIG. 42 with three rows ofstaples being shown in a cuff 19. Once the staples are deployed, theheart valve can be moved onto the stapled cuff, and attached thereto asabove discussed. This is illustrated in FIGS. 43-45. As shown in FIG.38, the staples extend through the cuff and into the tissue before theyare folded over. Thus, as shown for staple 720a the staple legs extenddeep into the tissue to get full depth bite of tissue before folding,and the cuff is stretched over the tissue as shown for tissue AT.

As above discussed, there are times when a surgeon wishes to apply onestaple at a time so better control over the number and placement of thestaples can be exercised. This can be achieve using instrument 800 shownin FIGS. 46 and 47.

Instrument 800 fires one staple at a time and can be positioned asdesired prior to firing the staple. As will be discussed below, usinginstrument 800, a surgeon can establish any desired stapling pattern,either one preset on the cuff or one that the surgeon makes up on thefly. It is noted that the operation of the staple and the staple formingassembly of instrument 800 is basically identical to the staple andstaple forming assembly discussed above. Therefore, only the differencesbetween instrument 800 and the above-described assembly will bediscussed.

Instrument 800 includes a hand-grip section 802 on the proximal endthereof, and a staple forming and deploying assembly 804 on the distalend thereof with a shaft housing 806 connecting the two ends. Hand-gripsection 802 includes a handle 808 on which a forming trigger 810 ispivotally mounted for movement in directions 811 and 811′, with returnspring 812 biasing the trigger in return direction 811′. A drive bar 814is connected at a proximal end thereof to trigger 810 to be moved indirections 811 and 811′ with the trigger. Drive bar 814 is locatedinside housing 806 and has a staple driver 704″ on the distal endthereof. Staple driver 704″ is part of a staple driving and formingassembly 680″ which drives staple 720 toward center anvil 690″ to movethe legs of the staple outwardly and through the cuff and the tissue andthen to fold the legs over as above discussed. A lifter spring 694″ejects the staple after it has been formed. A plurality of staples arestored in a housing 816 on the distal end of the shaft, and a springbiased magazine guide 818 urges the staples under a transfer spring 820mounted on shroud 822 which biases the staples into position to be movedby the driver 704″ upon actuation of forming trigger 810. Operation ofthe staple forming assembly will not be discussed as it was discussedabove with reference to FIGS. 34a-34e′.

As shown in FIG. 47, distal end 804 is angled so a staple exits that endat an angle θ to the longitudinal centerline of the instrument. In thepreferred embodiment, angle θ is an acute angle. A flexible section 824between drive bar 814 and driver 704″ permits the drive bar to movelinearly while forcing the staple at an angle to that movement. Thepurpose of this angled discharge is to permit the surgeon to accuratelylocate the staple being driven in the exact position he desires. As willalso be understood from the following discussion, this angled dischargepermits the instrument 800 to be used in conjunction with a plurality ofdifferent systems.

As just mentioned, a surgeon may want to locate each stapleindividually. He may use a guide or he may simply locate on the fly. Oneform of stapling guide system, is shown in FIG. 48. Using this system, acuff is first attached to the patient's tissue using the just discussedstaple driving tool, instrument 800, in conjunction with a guide andsupport assembly 830. In the interest of clarity, a cuff that isinstalled on the patient separate from the heart valve will be referredto as an anchor ring. Once the anchor ring is installed on the patient,the heart valve is drawn to it in the manner discussed above, such asshown in FIGS. 43-45, for example. As shown in FIG. 48, an anchor ring19′ is releasably fixed to flexible fingers 832 of a cage, with the topof each finger being fixed to an index ring 834 and biasing outwardlyfrom that ring. The anchor ring 19′ is positioned on the lower ends ofthe fingers and is biased radially outwardly. The index ring 834 haslugs 836 that are fixed to a stationary stabilizer whereby the guide 830is held stationary during the operation. The outward flex of fingers 832force the ring 19′ against the patient's tissue thereby ensuring a snugfit between the anchor ring and the patient's tissue, and canaccommodate various sizes of aortas.

As can be seen in FIG. 48, anchor ring 19′ includes a plurality ofstapling icons, such as icon 838 to guide a surgeon in placing thestaples. Using icons 838, a stapling pattern shown in FIG. 49 will beestablished in ring 19′ with staggered rows R1, R2 and R3 of staples. Toassist the surgeon in following the icons, index ring 834 includes aplurality of grooves, such as groove 840 which receive the instrument800 and serve to position it with respect to an icon. If a surgeonwishes, he can staple in any pattern he wishes. This option isillustrated in FIG. 50 which shows a scalloped staple pattern thatgenerally follows the natural cusp shaped curves of a valve annuluscould be selected if desired. Other patterns could also be selected aswill occur to those skilled in the art based on the teaching of thisdisclosure.

As above described, the legs of each staple are first extended to piercethe cuff and the tissue to approximate the cuff or anchor ring on thetissue, then the staple is formed. The instrument is removed from thevicinity of a formed staple and is moved to the next groove. Once theanchor ring is stapled to the patient, the cage 830 is removed and theheart valve is located to be attached to the anchor ring as abovedescribed.

A more automated system for placing an anchor ring on a patient isillustrated in FIGS. 51-53. This system uses the above describedinstrument 849 and includes one system for locating the anchor ring anda second system for automatically indexing the location of the stapleplacement. Both system are shown in FIGS. 51 and 52.

The anchor ring is placed in the patient by first system 850 whichincludes two arcuate expander shoes 852 each pivotally connected atpivot 853 to an expander arm 854 at an arcuate section 856 of that armlocated near the distal end of the arm. A pivot 857 is located on thedistal end of each expander arm, and the proximal end of each arm islocated outside the patient during use. The surgeon grasps each of theexpander arms near the proximal ends 858 thereof and manipulates thesearms to expand the anchor ring against the patient's tissue. An O-ring860 exerts a radially inward bias that opposes outward movement of theexpander shoes. Cuff liners, such as cuff liner 860 are interposedbetween the expander shoes and the O-ring and contact the anchor ring.Cuff liners 862 serve as an outer circumferential edge of the system849.

System 849 further includes a top guide element 864. Element 864includes a central section 866 and two wing sections 868. Centralsection 866 accommodates the top end of guide tube 870 through whichinstrument 800 fits to be guided into stapling position within thepatient. A key hole slot 871 can engage a key 872 (see FIG. 46) onhousing 806 of instrument 800 to further control placement of theinstrument. As can be seen in FIG. 52, the bottom end of guide tube 870is positioned adjacent to the cuff liners and is angled with respect tothe plane established by the expander arms. The angled nature of thestaple discharge section discussed above thus places the staples in theproper position for discharge through the anchor ring and through thepatient's tissue to attach the anchor ring to the tissue. Each element864 further includes a plurality of ratchet teeth 870 that engage theexpander arms to hold them in a selected location and orientation.

The tool shown in FIG. 46 has only one set of drivers and thus themechanical complexity is low enough to make manufacturing efficient.Additionally, since manufacturing small parts is difficult, and smallparts do not handle stresses well, the reduction in parts for the FIG.46 tool is advantageous. Use of the system shown in FIG. 46 is evidentfrom the disclosure herein, and thus will only be briefly discussed.Once the diseased valve is removed and the tissue is decalcified, thevalve base alignment ring is placed down into the aorta and is held inplace with the stabilizing arms. Next, the surgeon looks down throughthe aorta at the cuff and uses the serrations on the inside of the ringto guide the staple driving tool toward the cuff. He then extends thelegs of the staple beyond the distal end of the driving instrument andplaces the staple according to the icons on the cuff. He then pushes thestaple legs through the cuff to penetrate the aortic tissue therebyapproximating the cuff to the tissue. Subsequently, he forms the staplewith the staple forming device and then removes the device. The deviceis then moved to the next serration, thereby stabilizing the top edge ofthe staple driving shaft and then places the protruding staple legs intothe next printed icon. The process is continued until either a helicalor circular staple pattern is established. The process is completed whenat least two overlapping rows of staples are formed in the cuff.

Once the anchor ring is securely stapled in place, the cuff is releasedfrom its attachment to the expander by cutting sutures and the tool isremoved. Docking sutures which were pulled up out of the body cavityduring the staple forming procedure are then sewn into the heart valvecuff and the valve is lowered into place either within the circumferenceof the anchor ring or superiorly depending on the configuration of theheart valve prosthesis. If the surgeon wants to adjust thesuperior/inferior placement he may do this by altering the placement ofthe docking sutures in the heart valve cuff.

The second element of the instrument 849 automatically indexes thelocation of the staple delivery. The second element includes a base 872that is located within the cuff liner and includes a central internallythreaded hole 874 and two pivot connections 876 to which pivots 857 ofthe expander arms are connected. The thread in hole 874 is helical for apurpose that will be discussed below. An idler plate 878 is mounted onbase 872 by pivot pin 880 being inserted into hole 882 defined in base872. An idler 884 is rotationally mounted on idler plate 878 and isengaged by index gear 886 that is also rotationally mounted on idlerplate 878. An idler plate spring 888 is mounted at one end thereof onbase 872 and at the other end thereof to idler plate 878 and is held inplace on base 872 by spring 889 mounted on base 872. Index gear 886 isconnected to a distal end of index drive shaft 890, with the proximalend of shaft 890 being attached to an index wheel 892. Index wheel 892is rotationally mounted to element 864 at a central location 894 havingindex indicators 896 thereon. Index drive shaft 890 is rotated byrotation of index wheel 892, with index indicators providing a visualindication of the amount of rotation undergone by the index drive shaft.As shown, rotation of index gear 856 in direction 897 causescorresponding rotation of idler 884 in direction 897′. Idler 884 isengaged with flexible gear rack 900 which is held in place on the cuffliners to engage the idler 884 to be moved in direction 897″ uponrotation of the idler in direction 897′. Flexible gear rack 900 is fixedto base 872. Since alignment tube 870 is fixed to base 872, tube 870will rotate with the base.

As shown in FIG. 53, heart valve HV is attached to cuff 19 and to heartvalve base holder 902. Base holder 902 includes arms 904 radiatingoutwardly from central section 906 on which an externally threadedprojection 908 is mounted. Thread groove 910 is helical and matinglyengages thread 912 defined on base 876 adjacent to hole 874. A retainerspring 914 ensures proper engagement between threads 910 and 912. Valvebase holder 902 is released from the heart valve by operating releaselever 916 connected to release shaft 918 to lift the shaft 918 upwardly.Lifting release shaft 918 causes fingers 904 to rotate inwardly torelease the anchor ring from the holder 902. The anchor ring is firmlysecured to the patient when the release lever is operated and theinwardly rotated arms are flexible enough to move past the fixed anchorring.

It is noted that the anchor ring is fixed to the patient by the outwardflexing of the arms 904, and an initial staple can be placed to furtherfix the anchor ring to the patient to begin the process. Thus, any itemfixed to the anchor ring is fixed, and any other element will move withrespect to the anchor ring after that ring is initially fixed to thepatient. Thus, since the base 872 is not fixed to the anchor ring, itwill rotate with respect to the anchor ring, while base holder 902 isfixed to the anchor ring. Thus, rotation of shaft 890 rotates the base872 with respect to holder 902. Since holder 902 is threadably engagedwith base 872, rotation of base 872 causes the base to movelongitudinally on the holder 872. Thus, base 872 moves both rotationallyand longitudinally on the cuff or anchor ring. The staple deliverylocation, being fixed to the base, thus moves both rotationally andlongitudinally with respect to the cuff. Such simultaneous rotationaland longitudinal movement causes the staple delivery location todescribe a helical path on the fixed cuff. Such a helical path is shownin FIGS. 54A-54C, for various sizes of staples and various staplespacings (21 mm spacing in FIG. 54A, and 21.5 mm spacing in FIG. 54C).This helical path permits a single line of staples to be set withoutunwanted gaps and with any degree of overlap desired.

The system shown in FIG. 51 assures that each staple is placed with theproper spacing between staples and that the rows are properly spaced. Inaddition, this alignment procedure is very forgiving and is adjustableto aorta diameter. This is because staples can be spaced apart a lineardistance instead of an arcuate distance. The staples are placed in asingle continuous row which takes the form of a helix to completeoverlapping multiple rows when the line is long enough to complete twoor more revolutions of the helix. It additionally allows the secondrevolution of the line to be placed much closer to the first revolutionbecause the line is not constrained by packaging multiple driverassemblies. The line distance is regulated only by how fine or coarsethe helix angle is on the index mechanism.

Use of the FIG. 51 system is evident from the above disclosure and thuswill only be summarized. The surgeon advances the staple in the tool toexpose the straight legs of the staple, The straight legs of the stapleare then pushed through the cuff to penetrate the aortic tissue.

Once the surgeon has felt the penetration of the staples into thetissue, he then forms the staple. Once the staple is formed and thelifter spring has lifted the staple off of the anvil, the staple drivingtool is removed from the receptacle. While holding on the proximal endof the tool, the index wheel is rotated one-half of a full rotation asindicated by colored markers on the index wheel as seen through theindex wheel indicators. The staple driving tool is then again insertedinto the staple alignment receptacle and keyed to maintain staplealignment. Once again, the staple legs are advanced forward andpenetrated through the cuff and the annular aortic tissue, then thestaple is fully formed. This process is repeated until two fullrotations of the indexing base are accomplished, thus providing twooverlapping helical rows of staples.

One form of the device has the timing wheel held within the indexingmechanism. The first step is to place the valve base and the cuff intothe aorta with the index valve holder. The second step is to dilate thecuff and make it snug against the aorta by using the dilation control onthe index valve holder. The internal platens, which press the cuffagainst the annulus expand. By expanding these platens, the indexingmechanism takes on the diameter of the distal section. This calibratesthe indexing mechanism for the specific annulus size. An incrementalmovement of the index planetary gear will make certain that thereceptacle has indexed the proper amount to ensure that the next stapleis fined precisely one increment from the previous staple, independentof annulus size. As the index mechanism is shifted to the next position,the planetary gear ensures that the mechanism will place the receptacleone increment away. After the staple driving device has fired the firststaple, the driving device is removed from the instrument and the indexholder is indexed to the next position. If desired, the device can formtwo rows of staples by extending the index feature to an upper positionafter firing a first row of staples.

With regard to the index gear 886, it is noted that each one-halfrotation thereof provide one staple increment. The index spring on thebase signals the user when the index gear has made one-half of arevolution through an audible tactile “click.” Further note that theflexible gear rack is connected at one end to one of four cuff linearparts and is allowed to float freely from thereon thereby allowing theindex gear rack to expand as the expander arms push on the cuff linersto accommodate larger or smaller sizes of aorta. In addition, the gearrack is taller than the index gear in order to allow the index gear tocontinue to engage the index rack as the alignment tube plate rises upthe threads to produce the helical pattern. It is also noted that theexpander arms are made of a slippery polymer to reduce friction with thecuff liners. Each shoe, through a small dovetail, engages at least twocuff liners.

A further use of the instrument 800 is illustrated in FIGS. 55 and 56for closing the aortomy 920. This procedure is achieved using staplesalone. The surgeon approximates the incised edges of the aorta withforceps 922, and tool 800 is placed next to the approximated edges andoperated to deploy a staple. Due to the dual movement of the staplediscussed above, the legs of the staple move through the tissue beforethey are folded over. As they fold over, the edges are brought togetherso formed staple 720f closes the incision as shown in FIG. 56.

As discussed above, the primary requirement for a fastener in thecontext of the present invention is to be individually placable andwhich locally approximates and cinches the tissue from the operativeside of the tissue.

The related applications referenced above disclose means and methods forreplacing a heart valve in which a flexible cuff is fixed to a patient'stissue and a prosthesis valve is then docked to the in-place cuff.Fasteners, such as staples, which have their shapes permanently changedby a tool are disclosed in these related applications. However, the cuffmounting procedure taught in these related applications, based on theteaching of these applications, can be carried out using a variety offasteners including, but not limited to, the permanently alteredfasteners mentioned above, fasteners which have their shapes changed bya tool during the process but which return to their initial shapes oncethey are fixed to the patient, and fasteners which do not have theirshapes altered by a tool during the cuff-attaching process. Thefollowing disclosure discusses the latter two fastener types.

The fasteners of the present invention, like nearly all surgicalmaterials, obey Hooke's law. That is, if they are subjected to agradually increasing stress, the ratio of the unit stress to the unitstrain or deformation, is constant until a certain limiting value of theunit stress, known as the proportional elastic limit, is reached, see,e.g., “The Making, Shaping and Treating of Steel” 10th Edition, editedby William T. Lankford, Jr., Norman L. Samways, Robert F. Craven andHarold E. McGannon and Published by US Steel and the Association of Ironand Steel Engineers in 1985, the disclosure of pages 1389-1446 (Chapter50) being incorporated herein be reference, see also the definition ofHooke's law in the McGraw-Hill Dictionary of Scientific and TechnicalTerms, published by McGraw-Hill Book Company in 1974 and edited byDaniel N. Lapedes (the disclosure of which is incorporated herein byreference), which defines Hooke's Law as “the law that the stress of asolid is directly proportional to the strain applied to it, “elasticdeformation” as “reversible alteration of the form or dimensions of asolid body under stress or strain,” and conversely “elastic failure” as“failure of a body to recover its original size and shape after a stressis removed,” “elasticity” as “the property whereby a solid materialchanges its shape and size under action of opposing forces, but recoversits original configuration when the forces are removed,” and “elasticlimit” as “the maximum stress a solid can sustain without undergoingpermanent deformation.”

Surgical fasteners can be treated within their elastic limit. In thisregard, elastic limit is defined in standard references, such as“Mechanics of Materials” by Seibert Fairman and Chester S. Cutshall,published by John Wiley & Sons in 1953, the disclosure of Chapters 1 and2, pages 1-32, being incorporated by reference, as the maximum stressthat may be applied without producing a permanent set. Such fastenerswill be referred to herein as elastic fasteners. With elastic fasteners,no permanent set occurs until after the proportional limit is reached,and the ratio of stress to corresponding strain for stress below theproportional limit is defined by ASTM as the modulus of elasticity.

Three types of fasteners that can be used to attach a prostheticreinforcing cuff to an annulus of an existing valve have been disclosed.The first type of fastener disclosed requires a forming step thattransfers a force to the fastener that causes the fastener to exceed itselastic limit thereby changing the actual shape and size of thefastener. The second type of fastener acts more like a spring in whichit initially changes shape within its elastic limit and returns to theoriginal shape of the fastener once application is completed. The thirdtype of fastener does not operate in the elastic range at all, therebynot changing shape in any way thus is a “self-retaining” fastener. Itmaintains its dimensional status throughout the application of thefastener.

As mentioned above and in U.S. Pat. No. 5,716,370, the disclosure ofwhich is incorporated herein by reference, the first type of fasteneruses an installation tool which imparts a force on the fastener causingit to exceed its elastic limit during application thereby physicallychanging the actual shape and size, and thus is a “tool formed”fastener. The definition of “elastic limit” in the McGraw-HillDictionary of Scientific and Technical Terms, published by theMcGraw-Hill Book Company in 1974 and edited by Daniel N. Lapedes (thedisclosure of which is incorporated herein by reference) is “the maximumstress a solid can sustain without undergoing permanent deformation.”Thus, from the foregoing, it can be understood that for materials suchas the fasteners of the present disclosure, which obey Hooke's Law,which is “the stress of a solid is directly proportional to the strainapplied to it,” permanent physical changes resulting from stressing thefasteners will disappear when the stress is removed providing the stressdoes not exceed the proportional elastic limit. After this limit isexceeded resulting strain does not entirely disappear when the stress isremoved. The part of the strain that remains is called the permanentset. A surgical staple an example of a fastener that surpasses itselastic limits and deforms during the attachment of a prosthesis to anannulus.

The second type of fastener disclosed as a non-anvil formed fastener andis a fastener that does not exceed its elastic limit and does not take apermanent set when used in attaching the prosthetic reinforcing cuff tothe annulus of an existing valve in the patient, and thus is referred toas a highly elastic fastener. These fasteners experience what is knownas “elastic deformation” which is defined as “reversible alteration ofthe form or dimensions of a solid body under stress or strain.” That is,they have the ability to regain their original, or initial shape anddimension, whatever that is, after experiencing a change of shape and/orsize, also known as strain, due to the application of external forces aslong as the external forces do not exceed the “elasticity” which isdefined as “the property whereby a solid material changes it shape andsize under action of opposing forces, but recovers its originalconfiguration when the forces are removed.” When an elastic material isused in this application it can temporarily change shape during theprocess of attaching the prosthesis to an annulus and once attached thefastener will retain the shape it had prior to attachment.

The third type of fastener does not see enough force to experience anyelastic deformation or even obtain elasticity whatsoever, and isreferred to as a self-retaining fastener. This fastener maintains itsoriginal shape and dimensions throughout the fastener application. Thisis also considered to be a non-anvil formed fastener, based on a certainamount of force being applied to it during the application of theprosthetic cuff but not enough to cause any dimensional changewhatsoever. An example of a non-anvil formed fastener that does notoperate in the elastic range is a self-tapping helical fastener or abarbed fastener.

Still further, since the present disclosure refers to fasteners such asstaples that have been stressed beyond their elastic limit whereby whenthe stressing force is removed the fasteners retain their stressed shapeand do not return to their initial size and/or shape, as being“tool-formed,” a fastener that has not been stressed beyond its elasticlimit and thus will return to its initial size and/or shape when thestressing force is removed will be referred to as a “non-formed” or“elastic” fastener. In other words, a non-formed fastener is a fastenerthat has been stressed during a surgical procedure, such as covered inthe present invention, yet is not permanently deformed by such stressand will return to its initial size, shape and dimensions when thestressing force is removed.

With regard to tool-formed fasteners, in order to set a tool-formedfastener to hold a cuff on a patient, a fastener such as a staple isstressed by a tool and anvil combination beyond the elastic limit of thefastener whereby once the forming force (the external stress) is removedthe fastener will not regain its original shape and will be permanentlydeformed. Elastic limits for most materials, including those used in thefasteners of the present invention, are well documented in standardreferences, such as in Table X of the above-referenced “Mechanics ofMaterials,” the disclosure of which is incorporated herein by reference,as well standard handbooks such as “Marks' Standard Handbook forMechanical Engineers” Seventh Edition Edited by Theodore Baumeister andpublished by McGraw-Hill Book Company in 1967, Chapter 5, the disclosureof Chapter 5 being incorporated herein by reference, as well as theincorporated US Steel Book. By way of example, the US Steel bookdiscloses the mechanical properties of stainless steel on pages1345-1355, the disclosure of which is incorporated herein by reference,including the yield strength thereof (see Table 47), see also theincorporated Mechanical Engineers Handbook, Table 19 (the disclosure ofwhich is incorporated herein by reference) while the mechanicalproperties of Titanium are disclosed in the incorporated MechanicalEngineers Handbook (see Table 21 on page 6-101), the disclosure of whichis incorporated herein by reference. Still further the incorporated“Mechanics of Materials” reference includes typical stress-straindiagrams for steel in FIGS. 26 and 27 on page 25, the disclosure ofwhich is incorporated herein by reference, that show the proportionallimits and illustrate Hooke's law.

The above discussion concerned a tool-formed fastener. As discussedabove, the present invention also encompasses elastic fasteners whichcan achieve the result of attaching a cuff to a patient without beingpermanently deformed during or by the attaching process or the tools orinstruments used to carry out the process. That is, the results of thepresent invention can be achieved using fasteners which, althoughstressed by the tool used and during the process of attaching the cuffto the patient using the fastener are not stressed beyond the elasticlimit thereof whereby once the cuff-attaching procedure is completed andthe tool removed from the fastener, the fastener will regain itsoriginal shape and dimension and will not be permanently deformed, ornon-formed.

FIGS. 57, 61, 63, 64 and 66 illustrate embodiments of the non-formed(not permanently deformed by the stresses associated with carrying outthe valve replacement procedures of the present invention) fastenerwhich achieves these objectives, while FIGS. 58-60, 63 and 67-68illustrate elements which can be used, either alone or in combinationwith tools disclosed hereinabove, to place these fasteners in a patientto attach a cuff to the patient without causing either the tool or theprocess to apply stress to the fastener sufficient to permanently deformthe fastener from its initial shape. That is neither the tool nor theprocess applies stress to the fastener beyond the elastic limit of thefastener whereby the fastener is non formed and will return to itsinitial size, shape and dimensions after the sewing cuff is attached tothe patient using the fastener. This is opposed to the staple form ofthe fastener discussed above which is permanently deformed during thecuff-attaching process, that is, the staple configuration of thefastener is “formed.”

As shown in FIG. 57, a pre-stressed fastener 1000 is shown in itsinitial shape and is monolithic and includes two legs 1002 and 1004which overlap each other adjacent to tissue penetrating points 1006 and1008 respectively. In a free condition, the legs overlap each other asshown in FIG. 57. Fastener 1000 is used by storing it in the freecondition such as shown in FIG. 57, then spreading the legs apart asindicated in FIG. 58 by fastener 1000′ before placing and inserting thefastener into and through the prosthesis and tissue to be connected. Thelegs are held apart until the fastener has been placed, and then thelegs are released. The procedure does not exceed the elastic limit ofthe fastener and thus the natural resiliency of the fastener causes thelegs to regain the FIG. 57 initial overlapping orientation therebycinching the prosthesis and tissue together. Fastener 1000 is formed ofhighly elastic material, such as nitinol or stainless steel spring wire,or the like having a shape memory and is not deformed beyond its elasticlimit by either the tool or the procedure used to attach a cuff to apatient.

A tool element 1000 _(T) is shown in FIGS. 58-60 and is used to placeand set fasteners 1000. Tool element 1000 _(T) is used with a tool thatimparts longitudinal movement thereto. Any tool discussed above can beadapted to impart such longitudinal motion in a minimally invasivesurgery environment. Referring to FIG. 58, tool element 1000 _(T)includes a fastener track 1010 supported on a tip retractor 1012 andhaving a cover 1014 thereon. Fasteners 1000 are stored in track 1010 andmove downwardly in the track 1010 under influence of either aspring-loaded pusher bar or advancing mechanism associated with theoperating tool. After the fastener reaches the end of the track, itdrops off of the track as can be seen in FIG. 59, and onto two extenderpins 1016 and 1018, best shown in FIG. 60. A hold-down spring 1020 keepsthe fastener properly oriented. Hold down-spring 1020 also moves afastener off the track into position to be opened against pins 1016 and1018. A retractor back up element 1022 is moved by the longitudinallymoving tool and forces the fastener against the pins 1020 to open thelegs into the position shown for fastener 1000′. Once the fastener isforced through the prosthesis and tissue, the tool element 1000 _(T) istwisted to withdraw it from the fastener. As soon as tool element 1000_(T) is withdrawn, legs 1002 and 1004 move toward the overlappingposition and cinch tissue and prosthesis together.

As above discussed, the present invention also encompassesself-retaining fasteners, and shown in FIG. 61 is one embodiment of sucha self-retaining fastener, and is a helical fastener 2000 which alsofulfills the above-discussed criteria for fastening a prosthesis to apatient and does not experience permanent deformation during or afterthe cuff-attaching procedure described herein. Fastener 2000 includes apolygonal head 2002 and a central body 2004 with a helical element 2006thereon. Element 2006 is in the nature of a screw thread, and uponrotating fastener 2000 in the manner of a screw, fastener 2000 acts likea self-tapping screw to force itself into and through a prosthesis andtissue to which the prosthesis is being attached.

A tool element 2000 _(T) suitable for use with rotational fastener 2000is shown in FIG. 62. Tool element 2000 _(T) can be used with any toolthat imparts rotational motion thereto. Tool element 2000 _(T) includesa rotation driver element 2010 which is connected to an element of theoperating tool and is located inside a driver tube 2012 and is connectedthereto to impart rotation thereto as indicated by arrow 2014. Drivertube 2006 fits over polygonal head 2002 to transfer this rotationalmotion to fastener 2000 which is located inside an extender tube 2016.

An operating tool 2000 _(TR) is used to impart rotational motion to thedriver element 2010 and is shown in FIG. 69 as including a housing 2030having a proximal end 2032 and a distal end 2034. Tool 2000 _(TR)translates linear motion of handle 2036 into rotational movement ofdriver shaft 2038 which is operatively connected to driver tube 2012which has a polygonal inside shape 2040 to match the polygonal shape ofhead 2002. Fasteners 2000 are located inside tube 2012 to haverotational motion imparted thereto.

Handle 2036 moves in direction 2042 relative to stationary handleportion 2044 about a pivot axis 2046 so end 2048 of handle 2036 moves indirection 2050. End 2048 includes an elongated slot 2052 in which a pin2054 is located. Pin 2054 is mounted on a follower sleeve 2056. Sleeve2056 is constrained so sleeve 2056 moves linearly in direction 2058 whenhandle 2036 is moved in direction 2042. A second pin 2060 is mounted onsleeve 2056 and moves therewith. Sleeve 2060 is located around a driverelement 2062 having a helical groove 2064 defined therein to receive pin2060. Driver element 2062 is rotatably mounted in housing 2030 by mounts2066 and flange 2068 so it can rotate but not translate under theinfluence of pin 2060 in groove 2064. Rotation of driver element 2062 isindicated by arrow 2070.

Driver element 2062 is operatively connected to shaft 2038 by one-waypawl mechanisms 2072 and 2074 so rotation in the desired direction istransmitted. Pawl mechanism 2074 transmits rotational movement ofelement 2062 to element 2038, while mechanism 2072 prevents retrogrademotion when handle 2036 is moved in the direction opposite to direction2042. Tool 2000 _(TR) also includes a stationary sleeve 2076.

Using tool 2000 _(TR) in connection with tool element 2000 _(T),fasteners are deployed in the center of the rotating tube. The rotatingtube has a distal end which has a jaw assembly to hold the fasten whichwill extend from the end of the instrument as it is driven into theprosthesis and tissue. In addition, there is an indexing mechanism whichadvances one fastener at a time into the driving jaw assembly.Rotational mechanisms in the housing then rotate both the storage tubeand the jaw assembly upon actuation of the handle as above described.The helix essentially screws its way into the tissue. Once the tissuebunches up against the head of the fastener, it compresses the tissue tothe prosthesis thereby creating a seal. Other fastener forms can also beused without departing from the scope of this disclosure which use aload bearing surface and tissue gathering means and which are notpermanently deformed by or during the cuff-attaching process so theywill regain their initial shape and/or size after completion process. Bythis, it is meant that there are essentially two components of such afastener, a crown surface which stays on the outside of the object to befastened and the fastening mechanism or extension legs which penetratethrough the fastening media into the tissue to grip the tissue. Yetanother form of this non-permanently deformed helical fastener is shownin FIG. 63 as fastener 2000′ having a polygonal head 2000 _(H) and ahelical body 2080 attached at one end thereof thereto and having a point2082 at the other end thereof.

Yet another form of such non-permanently deformed fastener is shown inFIG. 64 as fastener 2000″. Fastener 2000″ includes a head 2000 _(H)′having a knurled outer edge 2090 and to which a helical element 2092 isattached. Element 2092 has a penetrating point 2094 on the distal endthereof and regains its initial shape after completion of the surgicalprocess because neither the process nor the tools used in the processapplied sufficient stress to the fastener to exceed the elastic limit ofthe fastener.

Yet another fastener which is not permanently deformed by or during theprocess involving the fastener is shown in FIG. 65 as barbed fastener2000′″ which includes a head 2100 to which a central base 2102 isattached. Base 2012 has a pointed end 2104 and anti-back up barbs 2106mounted thereon. Barbs 2106 extend in a direction opposite to point 2104so once the fastener is set, the barbs will prevent it from moving in anopposite direction. A centrally located hole 2110 receives a point 2104of an adjacent fastener so the fasteners can be stored as indicated inFIG. 67 in a delivery tool element 2000 _(T)′″. Tool element 2000 _(T)′″is shown in FIGS. 67 and 68 as including a housing 2112 having aproximal end 2114 and a distal end 2116. Slots 2118 and 2120 are definedin end 2114 to slidably receive an advance bar 2122 that is movedlongitudinally by a tool operating element that imparts suchlongitudinal movement in a minimally invasive surgical setting. Bar 2122abuttingly contacts an antibackup ratchet 2124 on which fasteners 2000′″are releasably mounted. Fastener advance ratchets 2126 are oriented inthe manner of barbs 2106 to allow a fastener to move past the ratchetbut to prevent reverse movement of such fastener. Bar 2122 is forceddownwardly into housing 2112 in direction 2123 and forces the fastenersto exit end 2116 between arms 2128 and 2130. Fasteners slide over thearms and when set in the tissue or in the prosthesis, or both, the armsprevent the fastener from moving backwards in direction 2123′. The toolelement is then withdrawn and the fastener remains in place. Anantibackup post 2132 is also mounted on housing 2112.

A further form of non-permanently deformed fastener 2000′″ is shown inFIG. 66 as fastener 2000 ^(IV) which includes a circular base 2140having a base 2102 on one side and a post 2142 on the other side. Base2102 has a point 2104 on one end and antibackup barbs 2106 adjacent tothe point as discussed above for fastener 2000′″. Post 2142 is attachedto base 2140 by a one-way crimp 2144 and has a removable portion 2146connected to the base by a frangible joint 2148. Fastener 2000 ^(IV) isused in the manner of fastener 2000′″, is not stressed beyond itselastic limit during or by the process and thus the use and operationthereof will not be discussed. Removable portion 2146 is used to placeand set the fastener, and is then removed once the fastener is set. Atool driver is connected to portion 2146 in the manner of element 2000_(T)′″.

It is understood that while certain forms of the present invention havebeen illustrated and described herein, it is not to be limited to thespecific forms or arrangements of parts described and shown with theelements being shown, such as the tool T, being the best mode, but notthe only mode.

1. In combination: A) a multipart prosthesis which includes (1) aflexible sewing cuff, (2) a prosthesis valve separate and spaceable fromsaid flexible sewing cuff, and (3) means for securely attaching saidprosthesis valve to said flexible sewing cuff after said flexible sewingcuff has been attached to a patient; and B) a tool for attaching saidflexible sewing cuff to the patient in a minimally invasive manner andwhich includes (1) a housing, (2) an operating handle mounted on one endof said housing, (3) at least one fastener stored in said housing, saidfastener having an elastic limit, (4) means for releasably mounting saidflexible sewing cuff to said tool, and (5) a fastener handling means onsaid housing and operationally connected to said operating handle to becontrolled by said operating handle for storing said fastener andsecuring said fastener through said flexible sewing cuff and into thepatient's tissue from one side of said sewing cuff and the tissue toattach said flexible sewing cuff to the patient without deforming saidfastener beyond its elastic limit.
 2. The tool defined in claim 1further including means for separating the tool from the prosthesis. 3.In combination: A) a multipart prosthesis which includes (1) a flexiblesewing cuff, (2) a prosthesis valve separate from said flexible sewingcuff, and (3) means for attaching said prosthesis valve to said flexiblesewing cuff after said flexible sewing cuff has been placed in apatient; and B) a tool for placing said flexible sewing cuff in thepatient in a minimally invasive manner and which includes (1) a housing,(2) an operating handle mounted on said housing, (3) at least onefastener stored in said housing, said fastener having an elastic limit,(4) means for releasably mounting said flexible sewing cuff to saidtool, and (5) a fastener handling means on said housing andoperationally connected to said operating handle to be controlled bysaid operating handle for storing said fastener and securing saidfastener through said flexible sewing cuff and into the patient's tissuefrom one side of said sewing cuff and the tissue to attach said flexiblesewing cuff to the patient without deforming said fastener beyond itselastic limit.
 4. The combination defined in claim 3 wherein eachfastener of the tool includes a tissue-penetrating portion and anchoringmeans on said tissue-penetrating portion for anchoring saidtissue-penetrating portion after the tissue-penetrating portion haspassed through the patient's tissue.
 5. The combination defined in claim4 wherein the tissue-penetrating portion includes two legs and theanchoring means includes a spring base which is biased to force the legsof the tissue-penetrating. portion tissue-penetrating portion into aposition in which the legs overlap each other.
 6. The combinationdefined in claim 3 wherein the fastener of the tool includes a helicalportion.
 7. The combination defined in claim 3 wherein each fastener ofthe tool includes a tissue-penetrating portion which includesanti-backup barbs.
 8. The combination defined in claim 3 wherein saidfastener handling means includes of the tool includes means for storingfasteners and means for opening fasteners.
 9. The combination defined inclaim 3 wherein said fastener handling means includes of the toolincludes means for storing fasteners and means for imparting rotation tosaid fasteners.
 10. The combination defined in claim 3 wherein saidfastener handling means of the tool includes means for storing fastenersand means for advancing fasteners one at a time.
 11. The combinationdefined in claim 1 further including means for operating said operatinghandle which includes a housing; a handle pivotally mounted on saidhandle; means for translating pivoting movement of said handle intorotational motion; and means for connecting the translating means to afastener.
 12. In combination: A) a heart valve prosthesis which includes(1) a flexible sewing cuff, (2) a prosthesis valve body separate fromsaid flexible sewing cuff, and (3) means for securely attaching saidvalve body to said flexible sewing cuff after said flexible sewing cuffhas been placed in a patient; and B) a tool for placing said flexiblesewing cuff in the patient in a minimally invasive manner and whichincludes (1) a housing, (2) an operating handle mounted on said housing,(3) at least one fastener stored in said housing, said fastener havingan elastic limit, (4) means for releasably mounting said flexible sewingcuff to said tool, and (5) a fastener handling means on said housing andoperationally connected to said operating handle to be controlled bysaid operating handle for storing said fastener and securing saidfastener through said flexible sewing cuff and into the patient's tissuefrom one side of said sewing cuff and the tissue to attach said flexiblesewing cuff to the patient without deforming said fastener beyond itselastic limit.
 13. In combination: A) a multipart heart valve prosthesiswhich includes (1) a flexible sewing cuff, (2) a prosthesis heart valvebody separate from said flexible sewing cuff, (3) means for attachingsaid heart valve body to said flexible sewing cuff after said flexiblesewing cuff has been placed in a patient; and B) a tool for placing saidflexible sewing cuff in the patient in a minimally invasive manner andwhich includes (1) a housing, (2) an operating handle mounted on saidhousing, (3) at least one fastener stored in said housing, said fastenerhaving an elastic limit, (4) means for releasably mounting said flexiblesewing cuff to said tool, and (5) a fastener handling means on saidhousing and operationally connected to said operating handle to becontrolled by said operating handle for storing said fastener andsecuring said fastener through said flexible sewing cuff and the tissueto attach said flexible sewing cuff to the patient without deformingsaid fastener beyond its elastic limit.
 14. In combination: A) a heartvalve prosthesis which includes (1) a flexible sewing cuff, (2) aprosthesis valve separate from said flexible sewing cuff, and (3) meansfor securely attaching said valve to said flexible sewing cuff aftersaid flexible sewing cuff has been placed in a patient; and B) a toolfor placing said flexible sewing cuff in the patient in a minimallyinvasive manner and which includes (1) a housing, (2) an operatinghandle mounted on said housing, (3) at least one fastener stored in saidhousing, said fastener having an elastic limit, and (4) a fastenerhandling means on said housing and operationally connected to saidoperating handle to be controlled by said operating handle for storingsaid fastener and securing said fastener through said flexible sewingcuff and into the patient's tissue from one side of said sewing cuff andthe tissue to attach said flexible sewing cuff to the patient withoutdeforming said fastener beyond its elastic limit.
 15. In combination: A)a heart valve prosthesis which includes (1) a flexible sewing cuff, (2)a prosthesis valve separate and spaceable from said flexible sewingcuff, and (3) means for securely attaching said valve to said flexiblesewing cuff after said flexible sewing cuff has been placed in apatient; and B) a tool for placing said flexible sewing cuff in thepatient in a minimally invasive manner and which includes (1) a housing,(2) an operating handle mounted on said housing, (3) at least onefastener stored in said housing, said fastener having an elastic limit,and (4) a fastener handling means on said housing and operationallyconnected to said operating handle to be controlled by said operatinghandle for storing said fastener and securing said fastener through saidflexible sewing cuff and into the patient's tissue to attach saidflexible sewing cuff to the patient without deforming said fastenerbeyond its elastic limit.
 16. In combination: A) a multipart prosthesiswhich includes (1) a flexible sewing cuff, (2) a prosthesis valveseparate and spaceable from said flexible sewing cuff, and (3) anchorelements for securely attaching said prosthesis valve to said flexiblesewing cuff after said flexible sewing cuff has been attached to apatient; and B) a tool for attaching said flexible sewing cuff to thepatient and which includes (1) a housing, (2) at least one fastenerstored in said housing in a tissue-penetrating shape and having anelastic limit, and (3) a fastener handling means on said tool forforcing said fastener into the patient from one side of said flexiblesewing cuff and the patient's tissue to attach said flexible sewing cuffto the patient and deforming said fastener beyond its elastic limit intoa cuff-retaining shape.
 17. In combination: A) a multipart prosthesisvalve includes (1) a flexible sewing cuff, (2) a prosthesis valveseparate and spaceable from said flexible sewing cuff, and (3) anchorelements for securely attaching said prosthesis valve to said flexiblesewing cuff after said flexible sewing cuff has been attached to apatient; and B) a tool for attaching said flexible sewing cuff to thepatient and which includes (1) a housing, (2) at least one fastenerstored in said housing, said fastener being self-tapping to penetratethe patient's tissue when rotated, (3) a fastener handling means on saidtool for imparting rotation to said fastener and forcing said fastenerinto the patient's tissue from one side of the patient's tissue toattach said flexible sewing cuff to the patient.
 18. In combination: A)a multipart prosthesis which includes (1) a flexible sewing cuff, (2) aprosthesis valve separate and spaceable from said flexible sewing cuff,and (3) anchor elements for securely attaching said prosthesis valve tosaid flexible sewing cuff after said flexible sewing cuff has beenattached to a patient; and B) a tool for attaching said flexible sewingcuff to the patient and which includes (1) a housing, (2) at least onefastener stored in said housing, and (3) a fastener handling means onsaid tool for forcing said fastener into the patient from one side ofthe patient's tissue and attaching said flexible sewing cuff to thepatient.
 19. In combination: A) a multipart prosthesis which includes(1) a flexible sewing cuff, (2) a prosthesis valve separate andspaceable from said flexible sewing cuff, and (3) anchor elements forsecurely attaching said prosthesis valve to said flexible sewing cuffafter said flexible sewing cuff has been attached to a patient; B) afastener for attaching said sewing cuff to the patient from one side ofsaid sewing cuff, said fastener having an elastic limit; and C) meansfor forcing said fastener through said sewing cuff and attaching saidsewing cuff to the patient without exceeding the elastic limit of saidfastener whereby said fastener is non-formed when said sewing cuff isattached to the patient by said fastener.
 20. In combination: A) amultipart heart valve prosthesis which includes (1) a flexible sewingcuff, (2) a prosthesis heart valve separate and spaceable from saidflexible sewing cuff, and (3) anchor elements for securely attachingsaid prosthesis heart valve to said flexible sewing cuff after saidflexible sewing cuff has been attached to a patient; B) a fastener forattaching said sewing cuff to the patient from one side of said sewingcuff, said fastener having an elastic limit and an initial shape; and C)means a tool carrying the fastener, the tool configured for forcing saidfastener through said sewing cuff and attaching said sewing cuff to thepatient without exceeding the elastic limit of said fastener.
 21. Incombination: A) a multipart prosthesis which includes (1) a flexiblesewing cuff, (2) a prosthesis valve separate and spaceable from saidflexible sewing cuff, said prosthesis valve being attachable to saidflexible sewing cuff after said flexible sewing cuff has been attachedto a patient, and B) a tool operative to attach said flexible sewingcuff to the patient in a minimally invasive manner, the tool including(1) a housing, (2) an operating member mounted on one end of saidhousing, (3) at least one fastener carried by said housing, saidfastener having an elastic limit, (4) mounting structure on said tooloperative to releasably carry said flexible sewing cuff, and (5)( 4 ) afastener carrier on said housing, said fastener carrier beingoperatively connected to said operating member such that actuation ofsaid operating member secures said fastener through said flexible sewingcuff and into the patient's tissue from one side of said sewing cuff andthe tissue to attach said flexible sewing cuff to the patient withoutdeforming said fastener beyond its elastic limit.
 22. In combination: A)a multipart prosthesis which includes (1) a flexible sewing cuff, (2) aprosthesis valve separate from said flexible sewing cuff and attachableto said flexible sewing cuff after said flexible sewing cuff has beenattached to a patient, and B) a tool operative to attach said flexiblesewing cuff in the patient in a minimally invasive manner, the toolincluding (1) a housing, (2) an operating member mounted on saidhousing, (3) at least one fastener stored in said housing, said fastenerhaving an elastic limit, (4) mounting structure on said tool operativeto releasably carry said flexible sewing cuff, and (5)( 4 ) a fastenercarrier on said housing, said fastener carrier being operativelyconnected to said operating member such that actuation of said operatingmember secures said fastener through said flexible sewing cuff and intothe patient's tissue from one side of said sewing cuff and the tissue toattach said flexible sewing cuff to the patient without deforming saidfastener beyond its elastic limit.
 23. In combination: A) a multipartprosthesis which includes (1) a flexible sewing cuff, (2) a prosthesisvalve separate and spaceable from said flexible sewing cuff, and (3)anchor elements configured to attach said prosthesis valve to saidflexible sewing cuff after said flexible sewing cuff has been attachedto a patient; and B) a tool operative to attach said flexible sewingcuff to the patient, said tool including (1) a housing, (2) at least onefastener carried by said housing, said fastener having atissue-penetrating shape and an elastic limit, and (3) a fastenerhandling device on said tool operating to force said fastener into thepatient from one side of said flexible sewing cuff and the patient'stissue to attach said flexible sewing cuff to the patient and therebydeform said fastener beyond its elastic limit into a cuff-retainingshape.
 24. In combination: A) a multipart prosthesis which includes (1)a flexible sewing cuff, (2) a prosthesis valve separate and spaceablefrom said flexible sewing cuff, and (3) anchor elements configured toattach said prosthesis valve to said flexible sewing cuff after saidflexible sewing cuff has been attached to a patient; and B) a tooloperative to attach said flexible sewing cuff to the patient, said toolincluding (1) a housing, (2) at least one fastener carried by saidhousing, said fastener being self-tapping to penetrate the patient'stissue when rotated, (3) a fastener handling device on said tooloperative to impart rotation to said fastener and thereby force saidfastener into the patient's tissue from one side of the patient's tissueto attach said flexible sewing cuff to the patient.
 25. In combination:A) a multipart prosthesis which includes (1) a flexible sewing cuff, (2)a prosthesis valve separate and spaceable from said flexible sewingcuff, and (3) anchor elements configured to attach said prosthesis valveto said flexible sewing cuff after said flexible sewing cuff has beenattached to a patient; and B) a tool operative to attach said flexiblesewing cuff to the patient, said tool including (1) a housing, (2) atleast one fastener carried by said housing, and (3) a fastener handlingdevice on said tool operative to force said fastener into the patientfrom one side of the patient's tissue and thereby attach said flexiblesewing cuff to the patient.
 26. In combination: A) a multipartprosthesis which includes (1) a flexible sewing cuff, (2) a prosthesisvalve separate and spaceable from said flexible sewing cuff, and (3)anchor elements configured to attach said prosthesis valve to saidflexible sewing cuff after said flexible sewing cuff has been attachedto a patient; B) a fastener for attaching said sewing cuff to thepatient from one side of said sewing cuff, said fastener having anelastic limit; and C) a tool carrying said fastener and operative toforce said fastener through said sewing cuff and thereby attach saidsewing cuff to the patient without exceeding the elastic limit of saidfastener, whereby said fastener is nonformed when said sewing cuff isattached to the patient by said fastener.
 27. In combination: A) amultipart heart valve prosthesis which includes (1) a flexible sewingcuff, (2) a prosthesis heart valve separate and spaceable from saidflexible sewing cuff, and (3) anchor elements configured to attach saidprosthesis valve to said flexible sewing cuff after said flexible sewingcuff has been attached to a patient; B) a fastener configured to attachsaid sewing cuff to the patient from one side of said sewing cuff, saidfastener having an elastic limit and an initial shape; and C) a toolcarrying said fastener and operative to force said fastener through saidsewing cuff thereby attach said sewing cuff to the patient withoutexceeding the elastic limit of said fastener and while retaining theinitial shape of said fastener.
 28. The combination of claim 20, whereinthe fastener comprises two legs that overlap each other in the initialshape.
 29. The combination of claim 28, wherein the tool comprises atool element configured for separating the legs of the fastener apartsuch that the legs regain the initial shape when the tool is withdrawnafter the fastener is forced through the sewing cuff.
 30. Thecombination of claim 29, wherein the tool element comprises a fastenertrack for storing a plurality of fasteners therein, the tool elementfurther comprising an advancing mechanism for moving fasteners down thetrack until the fasteners drop off the track.
 31. The combination ofclaim 29, wherein the tool element comprises an extender pin that holdsthe legs of each fastener apart before the fastener is released from thetool.
 32. The combination of claim 20, wherein the flexible sewing cuffis fully flexible so the cuff can be deformed to conform to tissue ofthe patient.
 33. The combination of claim 20, wherein the flexiblesewing cuff comprises polyester fabric.
 34. The combination of claim 20,wherein the anchor elements comprise drawstrings.
 35. The combination ofclaim 21, wherein the fastener comprises two legs that overlap eachother in an initial shape.
 36. The combination of claim 35, wherein thetool comprises a tool element configured for separating the legs of thefastener apart such that the legs regain the initial shape when the toolis withdrawn after the fastener is forced through the sewing cuff. 37.The combination of claim 36, wherein the tool element comprises afastener track for storing a plurality of fasteners therein, the toolelement further comprising an advancing mechanism for moving fastenersdown the track until the fasteners drop off the track.
 38. Thecombination of claim 36, wherein the tool element comprises an extenderpin that holds the legs of each fastener apart before the fastener isreleased from the tool.
 39. The combination of claim 21, wherein thetool further comprises mounting structure operative to releasably carrythe flexible sewing cuff.
 40. The combination of claim 21, wherein theflexible sewing cuff is fully flexible so the cuff can be deformed toconform to tissue of the patient.
 41. The combination of claim 21,wherein the flexible sewing cuff comprises polyester fabric.
 42. Thecombination of claim 21, wherein the multipart prosthesis comprisesanchor elements for attaching the prosthesis heart valve to the flexiblesewing cuff.
 43. The combination of claim 42, wherein the anchorelements comprise drawstrings.
 44. A system for implanting a prosthesisheart valve within an annulus in a heart of a patient, comprising: aflexible sewing cuff having a shape for implantation within the annulusin the heart; a tool carrying one or more fasteners, each fastenerhaving an elastic limit, an initial shape, and two legs that overlap inthe initial shape, the tool configured for separating the legs of eachfastener apart, and forcing the legs through the sewing cuff into tissueof the annulus to attach the sewing cuff to the patient withoutexceeding the elastic limit of each fastener; and a prosthesis heartvalve separate and spaceable from the sewing cuff, the prosthesis valvebeing attachable to the sewing cuff after the sewing cuff has beenattached to the annulus.
 45. The system of claim 44, wherein the toolcomprises a tool element configured for separating the legs of thefastener apart such that the legs regain the initial shape when the toolis withdrawn after the fastener is forced through the sewing cuff. 46.The system of claim 45, wherein the tool element comprises a fastenertrack for storing a plurality of fasteners therein, the tool elementfurther comprising an advancing mechanism for moving fasteners down thetrack until the fasteners drop off the track.
 47. The system of claim45, wherein the tool element comprises an extender pin that holds thelegs of each fastener apart before the fastener is released from thetool.
 48. The system of claim 44, wherein the tool further comprisesmounting structure operative to releasably carry the flexible sewingcuff.
 49. The system of claim 44, wherein the flexible sewing cuff isfully flexible so the cuff can be deformed to conform to tissue of thepatient.
 50. The system of claim 44, wherein the sewing cuff comprisespolyester fabric.
 51. The system of claim 44, wherein at least one ofthe sewing cuff and the prosthesis heart valve comprises anchor elementsfor securely attaching the prosthesis heart valve to the sewing cuff.52. The system of claim 51, wherein the anchor elements comprisedrawstrings.
 53. A system for implanting a prosthesis heart valve withina annulus in a heart of a patient, comprising: a flexible sewing cuffhaving a shape for implantation within the annulus in the heart; a toolcarrying one or more fasteners, each fastener having an elastic limit,an initial shape, and two legs that overlap in the initial shape, thetool configured for holding the legs of each fastener apart, and forcingthe legs through the sewing cuff into tissue of the annulus to attachthe sewing cuff to the patient without exceeding the elastic limit ofeach fastener; and a prosthesis heart valve separate and spaceable fromthe sewing cuff, at least one of the sewing cuff and the prosthesisheart valve comprising anchor elements for securely attaching theprosthesis heart valve to the sewing cuff.
 54. The system of claim 53,wherein the tool comprises a tool element configured for separating thelegs of the fastener apart such that the legs regain the initial shapewhen the tool is withdrawn after the fastener is forced through thesewing cuff.
 55. The system of claim 54, wherein the tool elementcomprises a fastener track for storing a plurality of fasteners thereinin the initial shape, the tool element further comprising an advancingmechanism for moving fasteners down the track until the fasteners dropoff the track.
 56. The system of claim 53, wherein the tool elementcomprises an extender pin that holds the legs of each fastener apartbefore the fastener is released from the tool.
 57. The system of claim53, wherein the flexible sewing cuff is fully flexible so the cuff canbe deformed to conform to tissue of the patient.
 58. The system of claim53, wherein the sewing cuff comprises polyester fabric.
 59. The systemof claim 53, wherein the anchor elements comprise drawstrings.
 60. Thesystem of claim 53, wherein the sewing cuff comprises an indicator forsignaling when the prosthesis heart valve is properly seated in thesewing cuff.
 61. The system of claim 60, wherein the indicator isconfigured for providing a tactile feedback when the prosthesis heartvalve is properly seated in the sewing cuff.
 62. A system for implantinga prosthesis heart valve within an annulus in a heart of a patient,comprising: a sewing cuff having a shape for implantation with theannulus in the heart; a tool carrying one or more fasteners, eachfastener having an elastic limit, an initial shape, and two legs thatoverlap in the initial shape, the tool configured for holding the legsof each fastener apart, and forcing the legs through the sewing cuffinto tissue of the annulus to attach the sewing cuff to the patientwithout exceeding the elastic limit of each fastener; and a prosthesisheart valve separate and spaceable from the sewing cuff, at least one ofthe sewing cuff and the prosthesis heart valve comprising anchorelements for securely attaching the prosthesis heart valve to the sewingcuff.
 63. The system of claim 62, wherein the tool comprises a toolelement configured for separating the legs of the fastener apart suchthat the legs regain the initial shape when the tool is withdrawn afterthe fastener is forced through the sewing cuff.
 64. The system of claim63, wherein the tool element comprises a fastener track for storing aplurality of fasteners therein in the initial shape, the tool elementfurther comprising an advancing mechanism for moving fasteners down thetrack until the fasteners drop off the track.
 65. The system of claim63, wherein the tool element comprises an extender pin that holds thelegs of each fastener apart before the fastener is released from thetool.
 66. The system of claim 62, wherein the sewing cuff is flexible.67. The system of claim 66, wherein the sewing cuff is fully flexible sothe cuff can be deformed to conform to tissue of the patient.
 68. Thesystem of claim 62, wherein the sewing cuff comprises polyester fabric.69. The system of claim 62, wherein the anchor elements comprisedrawstrings.
 70. The system of claim 62, wherein the sewing cuffcomprises an indicator for signaling when the prosthesis heart valve isproperly seated in the sewing cuff.
 71. The system of claim 70, whereinthe indicator is configured for providing a tactile feedback when theprosthesis heart valve is properly seated in the sewing cuff.
 72. Thesystem of claim 63, wherein the tool element comprises a fastener trackfor storing a plurality of fasteners therein in the initial shape, thetool element further comprising an advancing mechanism for movingfasteners down the track.